The Business - Eniware, LLC (“Eniware” or the “Company”) has developed a revolutionary surgical instruments sterilization device to reduce unnecessary deaths for use both in military and developing world settings – the portable and power-independent Eniware Portable Sterilizer or “EPS-25.”
Market Opportunity - ~5B people do not have access to essential safe surgery, in part, due to a lack of reliable electricity in 50-80% of healthcare facilities worldwide, resulting in 1.5MM avoidable deaths per year.
Key Benefit – Unlike the EPS-25, autoclaves (which require electricity and clean water to run) can cost thousands of dollars (initial purchase price plus maintenance and repair costs) and are not suited to battlefield or humanitarian crises conditions. The EPS-25 and the consumable, SterilnoxTM, are an inexpensive, portable, power-independent alternative to the autoclave and have been verified and validated as an effective sterilization tool in low-resource environments.
Management Team - Eniware was founded by Huma Malik and Dr. James Bernstein, a serial entrepreneur with multiple exits including an IPO*, and has assembled a highly distinguished Board of Directors and Advisors, with unique perspectives on military, public and private applications of the EPS-25.
Eniware, LLC, (the “Issuer”, “The Company”, or “Eniware”) is issuing up to $5,000,000 in Class A-2 Convertible Preferred Membership Units (the “Class A-2 Units” or “Securities”) to support final R&D, manufacturing, regulatory, sales and marketing functions prior to full commercial availability of the EPS-25.
*Past performance is not a guarantee of future performance.
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Eniware is a Delaware Limited Liability Company founded in 2012 by James Bernstein, MD, and Huma Malik. After identifying a lack of safe, essential surgery due to improper sterilization of surgical equipment, Eniware’s team developed the Eniware Portable Sterilizer (“EPS-25”).
The EPS-25 is a portable, power-free sterilization device that will enable safe, essential surgery where electricity is absent, intermittent, or unreliable.
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Eniware has completed a rigorous design, engineering prototype and manufacturability process according to ISO and QMS standards (ISO: 13485:2016 certification granted) for its EPS-25 product.
The Eniware Portable Sterilizer is a 25-liter device that effectively sterilizes surgical instruments and surgical equipment. The device uses nitrogen dioxide gas-based sterilization technology to overcome the limitations of other sterilization methods in low-resource settings.
Advantages of the EPS-25 include power-independence, low-cost, portability, easy use, and broad material compatibility. The device requires no electricity or other fuel sources to operate and is designed to be less expensive than current technologies. Eniware projects the cost of the EPS-25 to be $3,000 for retail purchasers, and cost of the SterilnoxTM module to be <$10/cycle. The EPS-25 is designed to operate at ambient temperatures, allowing for safe and effective use across diverse climate conditions.
The EPS-25 2.0 system for a basic surgical kit consists of the following:
The following vendors and suppliers are working directly with Eniware to support the adaptation and expansion of the EPS-25 2.0.
The EPS-25 has a predicate device in the market and a pathway to FDA clearance; Noxilizer’s clearance of 510(k) medical device (K160501). The Company will file for FDA clearance before receiving the C.E. mark and will be assisted in this effort by the USAF and Swearingen Regulatory Consulting.
The EPS-25 will be C.E. marked after the Company completes its submission carried out with the assistance of Emergo, a global medical device consulting company, and with the Notified Body, Intertek. The steps required include certification by MetLabs of electrical equipment to EN 61010-1, IEC 61010-1, IEC61010-2-40 standards, preparation of the technical volume, and preparation of the final submission documents. Additional testing may be required. Between the FDA approval and the C.E. Mark, The EPS-25 will be approved for sale in all of its target markets.
The EPS-25 has recently undergone testing and evaluation for form, fit, and function by the U.S. military. Overall, the device performed as advertised in bringing sterilizing capability for surgical instruments in a format with minimal logistical requirements. The EPS-25 has been deemed functional in the austere surgical environment trials completed by the USAF.
The EPS-25 was evaluated by 25 individuals familiar with joint austere surgical teams and was demonstrated at the Committee on Surgical Combat Casualty Care semiannual business meeting. Predominant comments by reviewers included:
Evaluators had recommendations concerning improvements and modifications to the EPS-25. Foremost recommendations by reviewers included:
Eniware has created a list of recommended enhancements based on the outcomes of the evaluation all of which, and more, have been achieved through their Design & Engineering contract with Gener8. To assist in accomplishing these objectives and ensure they meet military specifications, Eniware is currently negotiating its Cooperative Research and Development Agreement (“CRADA”) with the United States Air Force, 59th Medical Wing in San Antonio, TX.
Eniware, in collaboration with Johns Hopkins School of Medicine and their Global Health Program, carried out a usability study of the EPS-25 in Sierra Leone in June of 2018.
Eniware will make haste carefully and deliberately with a huge addressable market, listening to the market and learning from our initial deployments. Eniware has engaged with representatives of all market segments and has incorporated their feedback in both its functional and design requirements to meet needs, functionality, and price points.
Eniware has created the Early Adopters Program for the initial placement of the EPS-25 as it requires training, collaborative users, identification of issues, and essential enhancements. Proposed Early Adopters by market include:
Reports and exposure from these first programs will result in validation of the product and allow Eniware to quickly scale to address the substantial backlog of qualified interest in military and East Africa as well as the need their early marketing has already validated.
The proposed timeline for the Early Adopters Program includes:
Permitting the success of the Early Adopter Programs, Eniware will be able to ramp up manufacturing with confidence, establish reliable supply chains and product costs, develop pricing models, take orders from identified potential users, and convert early adopters into ongoing customers.
Eniware has had spent considerable time and effort in identifying and fostering relationships with key parties across the world. Initial target market relationships are identified below.
Nitrogen Dioxide gas is a rapid and effective sterilant for use against a wide array of microorganisms. NO₂ gas is a small molecule with a low boiling point, allowing it to easily diffuse and fill complex spaces. NO₂ can be toxic at high concentrations, however low levels of NO₂ are deployed during sterilization making this toxicity unlikely. NO₂ is dramatically safer than similar sterilant gasses such as hydrogen peroxide, ethylene oxide, and chlorine dioxide, is considerably less corrosive than other gases, and is neither flammable nor explosive.
NO₂ reacts with molecules through oxidation and nitration. Nitration causes degradation of DNA upon which late outgrowth studies have found no repair mechanisms, thus making NO₂ an effective sterilant. NO₂ sterilization works at room temperature without any electricity and is compatible with a wide array of surgical equipment including temperature and water sensitive devices.
The most resistant organism is Geobacillus stearothermophilus, a spore-former that is the biological indicator for both steam and vapor hydrogen peroxide sterilization. As seen in the graph on the right, NO₂ causes a log-linear population reduction of the bacteria as exposure time is increased. Log-linear analysis is used to examine the relationship between two or more categorical variables in hypothesis testing. The log-linear response used here allows for a model around which the sterilization cycle for a given device may be developed.
NO₂ sterilization is a proven process that has been licensed to Eniware.
Eniware has exclusive licenses, and filed multiple trademarks, for all power-free applications of the NO2 technology and has filed multiple patents which protect the Company in in Australia, Canada, Germany, European Union, France, Great Britain, India, Japan, Sweden, and the United States. The development of the Version 2.0 mentioned earlier in this document has led to additional I.P, which Eniware is actively pursuing protection for through patents.
In low- and middle-income countries, 90% of the population cannot obtain access to basic surgical care. Approximately 150 million additional surgeries are needed in LMICs each year, with the greatest need in sub-Saharan Africa and South Asia. An estimated 33 million surgeries are done annually with only 6% done in LMICs where 33% of the world’s population lives.
The diagram below reflects the proportion of the population without access to safe, affordable surgery and anesthesia.
Losses in economic productivity due to inaccessible basic surgical care in LMICs is estimated at $12.3T USD over the next 15 years. Thus, investing in surgical services in LMICs makes great economic sense.
2-3% of all complicated labor ends with obstetric fistula, a complication of childbirth where a hole is formed between the birth canal and bladder and/or rectum. The complication is caused by prolonged labor without access to proper medical treatment. These women are forced to live with a tube connected to them for the rest of their lives, and an estimated 3 million women are living in such condition. An estimated 23% of women with obstructed labor die from Caesarean sections in Sub-Saharan Africa.
The only form of sterilization that military surgical teams have access to is steam and the current model being used by the U.S. military has been in use since the 1960’s. While this sterilizer is still commercially available and operational, it requires significant power, clean water, and is large and bulky. These insufficiencies make the sterilizers unsuitable for field use, resulting in a scarcity of sterile surgical instruments.
The U.S. military alongside the Department of Defense (“DoD”) are looking for future sterilizers to include the following improvements: automated data logging, pre-vacuum cycles, reduced power and water consumption, and improved safety and effectiveness.
Eniware has engaged and is continuing to engage with the United States’ and other nation’s militaries. The message Eniware has received from all encounters emphasized an unmet need to provide for sterilization in austere and forward locations where electricity is scare, portability is vital, and surgical intervention is necessary. Recently, Eniware has received inquiries from Ukraine, where the need for the EPS is acute.
Natural disasters relentlessly cause great damage and loss of life across the world. In many circumstances, immediate surgical attention is required, often in places lacking electricity.
Even in the United States, a highly industrialized country, states have suffered the wraths of natural disasters leaving them without electricity. Puerto Rico, Houston, TX, Florida, and New York City have all suffered from hurricanes that left them in critical need for sterilization in the absence of electricity.
The United Nations Disaster Assistance and Coordination has responded to over 300 disasters since its inception in 1993. Natural disasters exemplify the need for sterilization in the absence of electricity even in industrialized nations.
The refugee crisis creates a large and growing demand for essential primary health services, including safe surgery. Displaced individuals total over 90 million refugees globally, with almost 3 million living in refugee camps in developing countries. This number increases by the day due to conflicts, climate change, natural disasters, and poverty. Basic essential surgery is in critically short supply in refugee camps.
Noxilizer, Inc. is a company that provides room-temperature nitrogen dioxide sterilization and rapid bio decontamination technologies that offer many benefits over traditional methods. James Bernstein, CEO of Eniware, founded Noxilizer and developed Eniware as a spin-out of the company.
Eniware has acquired a set of licenses for the use of the nitrogen dioxide patented technology from Noxilizer. Eniware has the exclusive licenses for all power-free applications of the NO₂ technology for the developing world, global disaster relief and emergency response, global militaries, and global veterinary market.
Noxilizer has licensed its technology for use in treating large spaces such as labs and there is no evidence as to licenses with other power-based applications. The Company does not view Noxilizer as a competitor, but instead as a collaborator.
Sterilization can be achieved through various processes including heat, chemicals, radiation, high pressure, and filtration. However, all of these methods use either electricity, water, are expensive and/or are non-portable.
An autoclave is a sterilization device that uses pressure and steam to reach and maintain a temperature that is too high for any microorganisms to live in. However, most autoclaves are large and expensive items that do not work without electricity, posing an issue in many circumstances.
The preceding financial projections reflect the Company’s best estimated forecasts and are not guaranteed to be accurate. The timing of performance is estimated post-funding. These figures are forward-looking statements and reflect the Company’s views about various future events or expectations. These figures take into account known and unknown risks, uncertainties and other factors and assumptions which may cause the Company’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by this forward-looking financial projection. Please see the note regarding forward-looking statements. A full version of this pro-forma financial model is available through carofin.com
The Company had raised approximately $4.6MM in two external equity financings to date prior to the $2MM received in this Class A-2 Offering, - the Class A Membership Units (functions as common equity of the Company), and the Class A-1 Membership Units (functions as preferred equity of the Company with anti-dilution provisions).
The Unit Price for the Class A Units was $16/Unit, and for the Class A-1, $22/Unit. The Class A-1 has certain anti-dilution provisions, which have been calculated into the Total Units Issued on the Capitalization Table below.
CFS did a comparable company analysis, which included the acquisition by Fortis of Advanced Sterilization Products, to determine a suitable revenue multiple for valuation, which was applied to 2024 revenue projections, resulting in a unit price of $19.17 per Class A-2 Unit.
Eniware has specified the use of the proceeds for both the short-term and the long-term. In the short-term, Eniware will use the proceeds to finalize regulatory approvals, ramp up manufacturing, and develop and carry out the Early Adopter Programs. The use of proceeds listed below assume that the commercial product will be rolled out aggressively in Eniware’s three market segments: military, developing world, and global disaster relief and emergency response, and that research and development will successfully continue in response to the market. If Eniware successfully obtains Department of Defense non-dilutional funding, they will be able to put a greater emphasis into sales and marketing.
On November 25, 2019, Eniware, LLC, James E. Bernstein, and Huma Malik were named as defendants in a lawsuit brought in the Circuit Court for Montgomery County, Maryland. The plaintiff alleged that the defendants, among other causes of action, were in breach of contract due to their failure to meet a payroll obligation on October 21, 2016, failure to make a severance payment, and failure to make a payment related to the purchase of the plaintiff’s equity units in Eniware, LLC. The plaintiff seeks $64,837 in unpaid wages and that his Class B Units in the Company be returned to him.
On June 11, 2020, the court dismissed the complaint due to the breach of contract claim being barred by Maryland’s three-year statute of limitations; the remaining causes of action were denied by the court on December 30, 2020, when the court denied the plaintiff’s motion for reconsideration.
On September 27, 2021, the plaintiff filed a brief in the Court of Special Appeals of Maryland, where the plaintiff’s request that the case be remanded to the circuit court remains pending.
Carolina Financial Securities, LLC (“CFS”) is offering up to $5,000,000 of Class A-2 Convertible Preferred Membership Units (the “Offering”, “Securities” or the “Class A-2 Units”) by Eniware, LLC. (“Eniware” the “Company” or the “Issuer”).
Proceeds from this Offering will be used, as (i) as growth capital by Eniware to fund the development and expansion of its EPS-25 and Sterilnox™ module supply chain (ii) sales and marketing expenses; (iii) working capital reserve; and (iv) to pay fees and expenses associated with this Offering.
Eniware, LLC (“Eniware” the “Company” or the “Issuer”), a medical device company which has developed a revolutionary power-independent NO₂ sterilization process for surgical instruments and devices, for use by military, public and private medical professionals.
Class A-2 Convertible Preferred Membership Units (the “Offering”, “Securities” or the “Class A-2 Units”) of the Issuer, offered privately in accordance with S.E.C. Regulation D, Rule 506(c). Investors will become members of the Company and execute a joinder to the Company’s Second Amended and Restated Operating Agreement, as amended (the “Operating Agreement”)
up to $5,000,000.
The effective pre-money valuation for this offering is $19,594,972. The implied post-money valuation is $24,594,972, with the Class A-2 Membership Percentage representing 20.29% of the Company assuming the exercise of convertible notes, but not certain warrants. Please see the Pro-Forma Capitalization Table enclosed herewith.
The Company has authorized the issuance of up to 260,778 Class A-2 Units. The price per Class A-2 Unit shall be $19.17, representing 20.29% of the Company’s ownership after the conversion of certain outstanding convertible notes, and additional issuance of Class A-1 Units as per anti-dilution provisions provided for in the Operating Agreement.
All Investors in the Class A-2 Units (the “Class A-2 Members” or “Investors”) must qualify as an “Accredited Investor” as defined within Regulation D, Rule 501 as promulgated by the U.S. Securities Exchange Commission
To generate capital gains for Investors.
On or around March 1st, 2022, the Company conducted an initial closing of the Offering with the purchase of $1,000,000 of Securities by a sole Investor. Additional investments will be funded directly to the Company upon the full execution of closing documents.
This Offering will expire at the earlier of (i) such time when $5,000,000 of Class A-2 Units have been issued, or (ii) upon the election of the Company to terminate the Offering.
The Class A-2 Units will carry an annual 6.00% cumulative dividend which shall accrue until paid in connection with a liquidation event as defined below
In the event of any liquidation, dissolution or winding up of the Company, the Class A-2 Members shall first be paid as follows:
First, to pay one and a half times the original purchase price plus accrued dividends plus declared and unpaid dividends on each of the Class A-2 Units (or, if greater, the amount that the Class A-2 Members would receive on an as-converted basis). The balance of any proceeds shall be distributed pro rata to Class A, Class A-1 and Class B Members.
A merger or consolidation (other than one in which Members of the Company own a majority by voting power of the outstanding shares or units of the surviving or acquiring entity) and a sale, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Company will be treated as a liquidation event (a “Deemed Liquidation Event”), thereby triggering payment of the liquidation preferences described above unless the majority of Class A-2 Members choose to convert into Class A Units as defined below under Optional Conversion. The Investors' entitlement to their liquidation preference shall not be abrogated or diminished in the event part of the consideration is subject to escrow in connection with a Deemed Liquidation Event.
The Class A-2 Units initially convert at a 1:1 ratio to Class A Membership Units at any time at the option of the Class A-2 Member, subject to adjustments for dividends, splits, combinations and similar events and as described below under “Anti-Dilution Provisions.”
Each Class A-2 Unit will automatically be converted into Class A Units at the then applicable conversion rate (i) in the event of the closing of an underwritten public offering or equity financing with a price of 2 times the original purchase price (subject to adjustments for dividends, splits, combinations and similar events) (a “Qualified Financing”) or (ii) upon the written consent of the members of 66 2/3% of the Class A-2 Convertible Preferred.
Broad based weighted average anti-dilution protection against additional equity being issued or options granted at a value lower than that implied at the closing of this Offering. Options or Warrants approved by the Board of Directors for issuance to management, consultants and/or key employees shall not trigger anti-dilution adjustment. This anti-dilution protection does not apply to anticipated subsequent rounds of financing needed to grow the Company that are sold at a higher valuation than that implied at the closing of this Offering.
Class A-2 Members will have voting rights as defined in the Operating Agreement.
The Company will provide financial reporting, including quarterly, year-to-date and annual income, balance sheet and cash flow statements as compared to the current budget and compared to results for the comparable period for the prior year to Class A-2 Members and the Administrative Agent. An annual review will be performed within 120 days of year-end by a third-party auditor as designated by the Company. The coming year’s annual budget will be provided to each Member within 30 days of each fiscal year-end for as long as they continue to be a member of the Company.
So long the Class A-2 Units are outstanding and Members representing 66.6% of the Class A-2 Units have voted affirmatively to request that their representatives conduct an inspection of the Issuer, Members shall be entitled to standard inspection rights upon reasonable notice.
All Class A-2 Members shall have preemptive rights to purchase additional units, up to the amount of their ownership percentage of the Company on an as-converted basis, in bona fide offerings for capital raising purposes until such time as the Class A-2 Units convert to Class A Membership Units, and/or a sale or merger of the Company occurs, subject to customary exclusions, including without limitation: (i) issuances of management/employee/director/consultant incentive equity, (ii) equity issued at any time pursuant to any currently outstanding debt instruments, options or warrant agreements (ii) equity securities issuable upon exercise of any options or other equity security equivalents, (iv) equity securities issued in connection with bona fide third party financing transactions and (v) equity securities issued in connection with acquisitions and other strategic transactions.
Should any single Class A-2 Member or member of any class owning five percent (5%) or more of the Company’s total equity make a private sale of its Units (to someone other than another employee, officer or Director or then current Member of the Company, or a transfer pursuant to estate planning), then the Class A-2 Members would be entitled to participate, pro rata, in the sale (i.e., a Tag-Along Right).
If a Class A-2 Preferred Member, or a Class A, Class A-1 or Class B member, or a group of members owning more than sixty six and two thirds percent (66 2/3%) of the total Units of all classes (“Selling Members”) decide to (i) sell their Units to an unrelated third party, (ii) sell or license all or substantially all of the Company’s assets to an unrelated third party or (iii) consummate a similar “sale of the company” transaction, and such transaction is unanimously approved by the Company’s Board, then they shall have the right (i.e., a Drag-Along Right) to require the remaining members of all classes to sell their Units at the same price and on the same terms as offered by the third party for the Selling Members’ Units; subject to standard exceptions and requirements.
The Class A-2 Units are subject to resale restrictions under applicable securities laws and are not registered for sale with the Securities and Exchange Commission. Any third-party to whom Class A-2 Units are sold must become a member of the Company and execute a joinder to the Company’s Second Amended and Restated Operating Agreement, as amended (the “Operating Agreement”).
Class A-2 Members, together as one class, will be granted the following registration rights after the Company’s IPO: (i) one demand registration for underwritten offerings, (ii) unlimited piggyback rights (including participation in the Company’s IPO, subject to underwriter approval) and (iii) rights to register Units in unlimited S-3 "shelf" offerings provided that the aggregate amount of the proceeds of any such S-3 offering is at least $5,000,000. All of the related expenses (except underwriters' discounts and commissions) incurred by the members shall be paid by the Company. The registration rights shall be subject to standard black out rights.
Standard representations and warranties as to due organization, existence in good standing and power to conduct its business will be provided by the Company in the purchase agreement. Standard representations and warranties typical of a private offering of equity units will be provided by each Investor, including as to status as an “accredited investor”, receipt of Private Placement Memorandum, Company’s operating agreement, and other offering documents and other materials as requested, and acknowledgement that the Offering is being made under exemption from registration requirements (Details to be found in the purchase agreement). In order to comply with the requirements of Rule 506(c), Each Investor shall be obligated to provide the Company with either: (i) third party confirmation of such Investor’s status as an “accredited investor”, or (ii) such information as reasonably requested by the Company to confirm such Investor’s status as an “accredited investor.
The closing of the Offering is subject to customary pre-conditions, including but not limited to:
A syndicate Broker-Dealer selling group shall receive both an 8.0% fee for all equity capital raised as well as warrants for Class A Membership Units of the Issuer as compensation for services rendered. The amount of these warrants will equal a number of Units equal to 8.0% of the Class A-2 Units purchased by Investors, for a purchase price equal to the Unit price for the Class A-2 Units. CFS may share up to 50% of its fees and warrants with Carofin, LLC, an affiliated Broker-Dealer, for its assistance in the placement of the Offering. All legal fees and out of pocket expenses relating to closing the Offering will be paid by Eniware with CFS expenses subject to the Engagement Agreement between Eniware and CFS.
CFG Financial Services, LLC (“CFG FS”), an affiliate of Carofin and Carolina Financial Securities will act as administrative agent for the Class A-2 Members, often coordinating reporting and other obligations between the Company and the Class A-2 Members. The Company will reimburse CFG FS for its reasonable out of pocket expenses.
Delaware
What is Carofin?
Carofin is a FINRA broker dealer, an investment bank headquartered in Brevard, North Carolina, that specializes in financing smaller businesses. Carofin’s parent company Carolina Financial Group, LLC, was established in 1995 and its affiliates have privately placed over $1.2 billion of debt and equity securities.
Is this security registered with the Securities Exchange Commission (S.E.C.)?
No. It is being privately placed under Rule 506c of Regulation D of the S.E.C.
Must Investors in the Company be Accredited Investors?
Yes. They must have household income of $300,000 (for married couples) OR a net worth of $1,000,000, excluding the value of their primary residence, OR qualify for an institutional category of investor.
Will Investors Continue to Receive Information About the Security After Issuance?
Given its role as the administrative agent, CFG Financial Services is able to keep Investors informed about any unexpected changes in the Issuer's business and general operational updates.
What if I have questions in the future about the Business’s performance?
Carofin will distribute updates to investors at least quarterly, including account statements. You should feel free to also email Carofin at [email protected] or telephone us at 828.393.0088
Company Specific FAQ can be provided upon request.
AN INVESTMENT IN THE SECURITIES IS SPECULATIVE AND IS SUITABLE ONLY FOR PERSONS OF SUBSTANTIAL FINANCIAL MEANS WHO CAN AFFORD TO LOSE THEIR ENTIRE INVESTMENT AND HAVE NO NEED FOR LIQUIDITY IN THIS INVESTMENT. AN INVESTMENT IN THE SECURITIES OFFERED HEREIN SHOULD NOT BE A MAJOR PART OF YOUR INVESTMENT PORTFOLIO. YOU SHOULD REVIEW THE RISKS OF THIS INVESTMENT WITH YOUR LEGAL OR FINANCIAL ADVISORS. THIS OFFERING INVOLVES SUBSTANTIAL RISKS. THESE RISKS INCLUDE, BY WAY OF ILLUSTRATION AND NOT LIMITATION, THE FOLLOWING: RISKS ASSOCIATED WITH THE FACT THAT THE MEMBERS WILL NOT HAVE THE RIGHT TO VOTE ON OR APPROVE MOST DECISIONS REGARDING THE BUSINESS AND, AS SUCH, WILL NOT BE IN CONTROL OF THEIR INVESTMENTS IN SECURITIES OF THE COMPANY AND THE BUSINESS; AND THE OPERATION OF THE COMPANY INVOLVES TRANSACTIONS BETWEEN THE COMPANY, THE MANAGER, AND THE OWNER WHICH MAY INVOLVE CONFLICTS OF INTEREST.
THE SECURITIES ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE AND MAY NOT BE TRANSFERRED OR RESOLD EXCEPT AS PERMITTED UNDER THE ACT, AND THE APPLICABLE STATE SECURITIES LAWS, PURSUANT TO REGISTRATION OR EXEMPTION THEREFROM, AND WITH THE PRIOR CONSENT OF THE MANAGER, WHICH CONSENT MAY BE WITHHELD IN THE MANAGER’S SOLE DISCRETION. PROSPECTIVE INVESTORS SHOULD BE AWARE THAT THEY WILL BE REQUIRED TO BEAR THE FINANCIAL RISKS OF THIS INVESTMENT FOR AN INDEFINITE PERIOD OF TIME.
SOME OF THE INFORMATION IN THIS PRESENTATION MAY CONTAIN “FORWARD-LOOKING” STATEMENTS. YOU CAN IDENTIFY SUCH STATEMENTS BY THE USE OF FORWARD-LOOKING WORDS SUCH AS “MAY,” “ANTICIPATE,” “ESTIMATE,” “COULD,” “SHOULD,” “WOULD,” “EXPECT,” “BELIEVE,” “WILL,” “PLAN,” “INTEND,” “PROJECT,” “PREDICT,” “POTENTIAL” OR OTHER SIMILAR WORDS. THESE TYPES OF STATEMENTS DISCUSS FUTURE EXPECTATIONS OR CONTAIN PROJECTIONS OR ESTIMATES WHICH MAY OR MAY NOT HAPPEN AS PROJECTED HEREIN. WHEN CONSIDERING SUCH FORWARD-LOOKING STATEMENTS, YOU SHOULD KEEP IN MIND THE RISK FACTORS LISTED BELOW, WHICH COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN ANY FORWARD-LOOKING STATEMENT.
YOU SHOULD CAREFULLY CONSIDER THE FOLLOWING RISK FACTORS IN CONJUNCTION WITH THE OTHER INFORMATION ABOUT THE SECURITIES BEFORE PARTICIPATING IN THIS OFFERING. THE RISKS DISCUSSED IN THIS PRESENTATION CAN ADVERSELY AFFECT THE COMPANY’S OPERATION, OPERATING RESULTS, FINANCIAL CONDITION AND PROSPECTS FOR SUCCESS. THIS COULD CAUSE THE VALUE OF THE SECURITIES OFFERED HEREIN TO DECLINE AND COULD CAUSE YOU TO LOSE PART OR ALL OF YOUR INVESTMENT. THE RISKS AND UNCERTAINTIES DESCRIBED BELOW ARE NOT THE ONLY ONES THE COMPANY FACES BUT DO REPRESENT THOSE RISKS AND UNCERTAINTIES KNOWN TO THE COMPANY AND THAT THE COMPANY BELIEVES ARE MATERIAL TO THE COMPANY’S FUTURE OPERATING PERFORMANCE.
The Securities being offered should be considered a speculative investment. The ability of the Company to achieve its objectives may be determined by factors beyond its control that cannot be predicted at this time. Consequently, there can be no assurance that the Company’s efforts to continue its business operations will prove to be sufficient to enable the Company to generate the funds required to make distributions. Anyone investing in the Securities should do so only if they are financially able to sustain the loss of their entire investment and should recognize that such a possibility exists.
As this security is a private transaction, there is currently no public market for the securities being offered herein. These Securities are not a publicly registered securities and will have no secondary sale liquidity.
The Company has a limited history of operations upon which an evaluation of the Company’s business and prospects can be based. No assurances can be given that the Company will ever be profitable or generate revenues sufficient to make distributions. This makes evaluating the Company’s business operations and validating its financial projections difficult. In assessing the Company’s prospects, a potential investor must consider the risks and difficulties frequently encountered by early-stage companies. These risks include the Company’s ability to: raise sufficient capital to fund operations, and other general corporate purposes; manage changing and expanding operations; establish and increase awareness of the Company’s brand and strengthen loyalty among prospective customers; implement and successfully execute the Company’s business and marketing strategies; respond effectively to competitive pressures and developments; continue to enhance the Company’s products and services; and attract, retain and motivate qualified personnel. The Company’s failure in any of these areas could adversely affect the Company’s financial condition and results of operation.
Units may be purchased by the affiliates of the Issuer, or by other persons who will receive fees or other compensation or gain dependent upon the success of the Offering. Such purchases may be made at any time and will be counted in determining whether the required minimum level of purchases has been met for the closing of the Offering. Therefore, Investors should not expect that the sale of sufficient Units to reach the specified minimum, or in excess of that minimum, indicates that such sales have been made to investors who have no financial or other interest in the Offering, or who otherwise are exercising independent investment discretion.
The sale of the specified minimum, while necessary to the business operations of the Issuer, is not designed as a protection to investors, or to indicate that their investment decision is shared by other unaffiliated investors. Because there may be substantial purchases by affiliates of the Issuer, or other persons who will receive fees or other compensation or gain dependent upon the success of the Offering, no individual investor should place any reliance on the sale of the specified minimum as an indication of the merits of the Offering. Each investor must make his own investment decision as to the merits of this Offering.
The Company’s Operating Agreement contains certain aspects which may affect the class as a whole upon the consent of a certain number of the outstanding Class A-2 Units and without the affirmative consent of Investors, which may include affiliates and employees of the Company as well as other parties with conflict of interest. As such, purchasers of the Securities shall carefully weigh how such governance mechanics may adversely affect them as it pertains to their membership in the Company.
The Company has an exclusive license to certain intellectual property directed to its proprietary portable sterilization platform. If the Company cannot meet its minimum payment obligations, it may lose its license. If we become involved in patent litigation or other proceedings to enforce our patent rights, we could incur substantial costs and expenses, substantial liability for damages, or be required to stop our product development and commercialization efforts.
The Company will be operating in countries in the developing world that may present unexpected problems, behaviors, and obstacles, which may have an adverse impact on sales and acceptance of our products.
Any substantial decline in the demand for products sold by the Issuer may cause a decline in the market value of Issuer’s product and negatively impact the Issuer’s financial performance.
Pricing for EPS-25 varies significantly depending on market conditions and vendor prices. This may negatively impact the Issuer’s financial performance.
Outbreaks of disease and other events, which may be beyond the company’s control, and producers who sell materials to Eniware, could significantly affect demand for its products, consumer perceptions of products, the availability of materials for purchase and its ability to conduct its operations.
Success for the Issuer’s business depends, in part, on the quality and safety of the Issuer’s products. If the products are found to be defective or unsafe, or if they otherwise fail to meet customer standards, relationships with customers could suffer. Further, the Issuer’s reputation could be diminished, and the Issuer could lose sales and/or become subject to liability claims, any of which could result in a material adverse effect on the business.
The Issuer’s activities are subject to international, federal, and state laws. The Issuer’s activities are expected to have a variety of regulatory oversight as development proceeds. Development of any of the Issuer’s operations will be dependent on the Issuer satisfying regulatory guidelines and, where required, being approved by governmental authorities. The Issuer intends to conduct their business activities in a compliant manner and in accordance with all applicable laws but may still be subject to accidents or other unforeseen events which may compromise its performance, and which may have adverse financial implications.
The Company competes with others in the industry. Competitors include companies that may have greater financial and other resources than the Company. Additionally, these competitors could use strategies to prevent the Company from achieving its objectives and may gain market share. This may have a material adverse impact on the financial position of the Company.
Any negative changes in economic conditions could have a material adverse effect on the Company’s business.
Due to the size of the organization, the Issuer has a significant reliance on certain key employees, particularly Dr. James Bernstein and Huma Malik. If the Issuer is unable to retain key employees it could jeopardize the Issuer’s ability to implement its business plan, its relationships with its customers, and its financial stability.
The Issuer expects to continue to grow its overall operations, and this may strain the Issuer’s resources. Any inability to manage growth effectively would have a material adverse effect on the Issuer’s business.
The Issuer reserves the right to accept or reject any proposed investment in its sole discretion. Subject to this discretion, it intends to accept investments on a “first-come, first-served” basis, with the consequence that Investors will be allocated a portion of the total Offering, based upon the amounts they have committed, in the order in which such commitments have been accepted. The Company is not required to accept all commitments tendered to it. There is no assurance, therefore, that your commitment will necessarily be accepted in whole or in part by it should it raise more or less funds than are needed to make its investments.
The financial projections contained in this Offering Summary and any supplements represent the Issuer’s estimated results of operations. The financial projections have been prepared upon the basis of assumptions and estimates which may differ from actual events and/or circumstances.
The Company has not requested and will not request any tax ruling from the IRS regarding the tax consequences of the Company’s activities. Accordingly, there is no certainty as to the tax consequences of participating in the Security. The Company has not sought or obtained a legal opinion with respect to the tax treatment of the offering proceeds or issuance of the Security. Accordingly, Investors are urged to consult your own tax advisor with respect to the federal and state tax consequences arising from participation in this Offering.
There is a possibility that the IRS will audit the Company’s income tax returns. If the Company’s income tax returns are audited, your return might also be audited.
No assurance can be given that the current Congress or any future Congress will not enact federal income tax legislation that could adversely affect the tax consequences of participating in the Offering.
Potential investors should not rely exclusively on one aspect of the security structure when making an investment decision on whether or not to participate in this Offering.
In addition to the above risks, businesses are often subject to risks not foreseen or fully appreciated by management. Prospective investors reviewing this Offering Summary should keep in mind other possible risks that could be important to the success of their investment in the Securities.
Important Disclosures
These securities have not been registered with the Securities and Exchange Commission (the “SEC” or the “Commission”), or with any state securities commission or any other regulatory authority. The securities are being offered in reliance upon an exemption from the registration requirement of federal and state securities laws and cannot be resold unless the securities are subsequently registered under such laws or unless an exemption from registration is available. Neither the SEC nor any other agency has passed on, recommended or endorsed the merits of this offering (this “Offering”) or the accuracy or adequacy of these confidential offering documents (the “Offering Package”). Any representation to the contrary is unlawful.
These securities are offered through Carofin, LLC, Member of FINRA/SIPC. Carolina Financial Securities is an affiliate of Carofin and both Broker-Dealers are affiliates of Carolina Financial Group, LLC. Documents have been prepared by Carolina Financial Securities and have been reviewed and approved by the management of the Company. The information contained herein has not been independently verified and is dependent on information provided by the Company to Carolina Financial Securities, LLC.
Our firms seek to present vital capital with meaningful investment opportunities through the fundamental analysis of the businesses we seek to finance. Such analysis is usually conducted through a First Principles approach.
When we provide you with a recommendation, we have to act in your best interest and not put our interest ahead of yours. At the same time, the way we make money creates some conflicts with your interests. You should understand and ask us about these conflicts because they can affect the recommendations we provide you. Here are some examples to help you understand what this means: Proprietary Products: Our firms will often present investments that are only available through them, which may result in a higher placement fee. The Firms will receive the placement fee regardless of your investment performing as expected.
Administrative Agent Services: CFG Financial Services, LLC, an affiliate of our firms, will act as Administrative agent for the securities while they are outstanding. Given that our firms have an interest in providing recurring services to the Issuer, while the administrative agent looks after the interests of investors, there may be a conflict of interest between the firms and its affiliates.
Our firms offer brokerage services to accredited investors, exclusively through the sale of private placements. the offerings we bring to market are carefully selected, and any recommendation you may receive from us will be limited to these offerings. Therefore, we may be unable to adequately compare the risks and benefits of the offerings we bring to offerings presented by other financial professionals. While our firms will often present new investments and discuss such investment’s risks and benefits with you, the ultimate authority to make such investment rests solely with you.
Our firms do not hold any investor cash or securities, and securities offered by us often have no easily assessable market value, so our firms will not monitor the market value of your investment on an ongoing basis. The investments we present often require a minimum investment of $5,000 for equity offerings and $10,000 for debt offerings.
Fees and costs may reduce any amount of money you make on your investments over time. Our firms are mostly compensated through placement fees, which are payable by the issuer, meaning that the firms will be compensated by receiving a percentage of the funds raised in an offering, regardless of the investment performing as expected. Such placement fee is usually between 3% and 7% (please find the specific Placement Fee for this offering in the “Placement Agent Fees” section of the “Security Terms”. Given that different investments have different placement fees, we may often have a conflict of interest when presenting these investments to you. The Firms’ bankers are often compensated by receiving a percentage of the placement fee, and may have their own conflict of interest when presenting you with offerings they structure.
The information contained herein is for informational purposes only and is not intended for further distribution. The information does not constitute a complete description of any investment or investment performance. This document is in no way a solicitation nor is it an offer to sell securities nor is it advice or recommendation regarding any investment. The information is not directed to any person who is not believed to qualify under the definition of an Accredited Investor under the rules of Regulation D of the 1933 Securities and Exchange Act. No security listed in this document or otherwise offered through Carolina Financial Securities, LLC or Carofin, LLC may be purchased without prior receipt of a complete Private Placement Memorandum or other official offer to sell.
Due diligence materials related to this Borrower and the Offering are available to you through Carolina Financial Securities’ affiliated marketplace, Carofin. If you have not received your login information to access Carofin.com, please contact your company representative to have access granted.
The Company will not offer, sell or issue any Securities in any jurisdiction where it is unlawful to do so or where laws, rules, regulations or orders would require the Company, in its sole discretion, to incur costs, obligations or time delays disproportionate to the net proceeds the Company will realize from such offers, sales or issuances. Neither this Offering Package nor any subscription agreement shall constitute an offer to sell or a solicitation of an offer to purchase any Securities in any jurisdiction in which such transactions would be unlawful.
Private placements are high risk and illiquid investments. As with other investments, you can lose some or all of your investment. Nothing in this document should be interpreted to state or imply that past results indicate future performance, nor should it be interpreted that FINRA, the SEC or any other securities regulator approves of any of these securities. Additionally, there are no warranties expressed or implied as to accuracy, completeness, or results obtained from any information provided in this document. Investing in private securities transactions bears risk, in part due to the following factors: there is no secondary market for the securities; there is credit risk; where there is collateral as security for the investment, its value may be imped if it is sold. Please see the Private Placement Memorandum (PPM), and the complete list of contents of this Offering Package for a more detailed explanation of the securities Summary of Terms, Investor Suitability Standards, Confidentiality, Securities Matters and Risk Factors.
Caution Regarding Forward-Looking Statements
Certain statements in this Summary Offering Material may be “Forward-looking” in that they do not discuss historical facts but instead note future expectations, projections, intentions, or other items relating to the future. We caution you to be aware of the speculative nature of forward-looking statements as these statements are not guarantees of performance or results.
Forward-looking statements, which are generally prefaced by the words “may,” “anticipate,” “estimate,” “could,” “should,” “would,” “expect,” “believe,” “will,” “plan,” “project,” “intend,” and similar terms, are subject to known and unknown risks, uncertainties and other facts that may cause our actual results or performance to differ materially from those contemplated by the forward-looking statements.
Although these forward-looking statements reflect our good faith belief based on current expectations, estimates and projections about, among other things, the industry, and the markets in which we operate, they are not guarantees of future performance. Whether actual results will conform to our expectations and predictions is subject to several known and unknown risks and uncertainties, including risks and uncertainties discussed in this Summary Offering Material.
Consequently, all the forward-looking statements made in this Summary Offering Material are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us or our business or operations. Risks, uncertainties, and factors that could cause actual results to differ materially from those projected are discussed in the “Risk Factors” section of this Summary Offering Material. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Considering these risks, uncertainties, and assumptions, the forward-looking events discussed in the Summary Offering Material might not occur.
SECURITIES MATTERS
State Securities Laws:
The Company will not offer, sell or issue any securities in any jurisdiction where it is unlawful to do so or where laws, rules, regulations or orders would require the Company, in its sole discretion, to incur costs, obligations or time delays disproportionate to the net proceeds the Company will realize from such offers, sales or issuances. Neither this Offering Package nor any subscription agreement shall constitute an offer to sell or a solicitation of an offer to purchase any securities in any jurisdiction in which such transactions would be unlawful.
PRIVATE PLACEMENTS ARE HIGH RISK AND ILLIQUID INVESTMENTS. AS WITH OTHER INVESTMENTS, YOU CAN LOSE SOME OR ALL OF YOUR INVESTMENT.
Securities offered through Carofin, LLC. Carofin, LLC and Carolina Financial Securities, LLC are affiliated Broker-Dealers, Members of FINRA/SIPC, and subsidiaries of Carolina Financial Group, LLC. For more information on the services we offer and details associated with such services, please see our Customer Relationship Summary.
This site is published for residents of the United States only. Representatives may only conduct business with residents of the states and jurisdictions in which they are properly registered. Therefore, a response to a request for information may be delayed until appropriate registration is obtained or exemption from registration is determined. Not all services referenced on this site are available in every state and through every advisor listed. For additional information, please contact Craig Gilmore at 828.393.0088 x 520 and/or [email protected]
The information contained herein is for informational purposes only and is not intended for further distribution. The information does not constitute a complete description of any investment or investment performance. This webpage is in no way a solicitation nor is it an offer to sell securities nor is it advice or recommendation regarding any investment. The information is not directed to any person who is not believed to qualify under the definition of an Accredited Investor under the rules of Regulation D of the 1933 Securities and Exchange Act. No security listed on this webpage or otherwise offered through Carofin, LLC may be purchased without prior receipt of a complete Private Placement Memorandum or other official offers of sale.
Carolina Financial Securities and Carofin only offer one type of alternative investment, those sold as private placements. Nothing on this website should be interpreted to state or imply that past results are an indication of future performance nor should it be interpreted that FINRA, the SEC or any other securities regulator approves of any of these securities. Additionally, there are no warranties expressed or implied as to accuracy, completeness, or results obtained from any information provided on this website. Investing in private securities transactions bears risk, in part due to the following factors: there is no secondary market for the securities; there is credit risk; where there is collateral as security for the investment, its value may be impaired if it is sold.
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