Vicapsys Life Sciences, Inc S-1, filed Jun 30, 2023

Vicapsys Life Sciences, Inc. (VICP)

S-1 2023-06-30

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Added on October 26, 2026

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Large accelerated filer ☐		Accelerated filer ☐
Non-accelerated filer ☒		Smaller reporting company ☒
		Emerging growth company ☒

	Per Share	Total
Public offering price	$	$
Underwriting discounts and commissions(7%)(1)	$	$
Proceeds to us, before expenses	$	$

		Page
PROSPECTUS SUMMARY		3
RISK FACTORS		13
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS		26
INDUSTRY AND MARKET DATA		27
USE OF PROCEEDS		27
DIVIDEND POLICY		27
CAPITALIZATION		28
DILUTION		29
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		30
BUSINESS		38
MANAGEMENT		61
EXECUTIVE AND DIRECTOR COMPENSATION		68
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS		70
PRINCIPAL STOCKHOLDERS		73
DESCRIPTION OF CAPITAL STOCK		74
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT		77
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR COMMON STOCK		78
UNDERWRITING		81
LEGAL MATTERS		87
EXPERTS		87
WHERE YOU CAN FIND MORE INFORMATION		87
INDEX TO FINANCIAL STATEMENTS		F-1

	●	Novel Approach: Our technology represents a paradigm shift in the treatment of conditions requiring immunosuppression in that with our approach there is no need for outside immunosuppressants to allow our cells to thrive in treatment.

	●	Enhanced Safety: Immunocompromised individuals often face challenges due to the long-term use of immunosuppressants including a high risk of life threatening cancers and infections. With our technology, we expect to eliminate or significantly reduce the need for these medications, leading to enhanced patient safety and well-being with a goal of patients experiencing improved health outcomes without the risks associated with immunosuppressive drugs.

	●	Improved Quality of Life: Living with a condition that requires chronic daily immunosuppression can be burdensome, involving strict medication regimens and constant monitoring. We believe our technology could eliminate the need for immunosuppressants, alleviating this burden and significantly improving the quality of life for patients.

	●	Potential Cost Savings: The long-term use of immunosuppressants can be financially demanding for both patients and healthcare systems and needs to be monitored on a very regular basis at healthcare facilities. However, our technology eliminates or reduces the need for these medications, potentially generating substantial cost savings in healthcare expenses. This benefits patients and healthcare providers alike, making treatment more accessible and affordable.

	●	Expanded Treatment Opportunities: With the elimination of immunosuppressive drugs, our technology opens doors to new treatment possibilities as it can be applied to a wide range of conditions that currently require immunosuppressive therapy, expanding its impact and benefiting numerous patient populations.

	●	Accelerated Recovery and Healing: Immune suppression often hinders the body’s natural healing processes. However, with our technology, we have successfully eliminated the need for immunosuppressants in non-human primates, promoting a more robust immune response. This can lead to faster recovery and healing in patients undergoing various medical interventions or treatments.

	●	Prevention of Fibrotic Overgrowth: Fibrotic overgrowth refers to the excessive formation of fibrous tissue, which can impede the healing process and lead to complications such as scar tissue formation and adhesions. By applying CXCL12, the risk of fibrotic overgrowth can be mitigated, promoting a more favorable healing environment and reducing the likelihood of adverse outcomes.

	●	Inhibition of Adhesion Formation: Adhesions occur when tissues or organs in the body become abnormally connected or stuck together. These adhesions can cause significant complications, such as pain, restricted movement, and organ dysfunction. The ability of CXCL12 to prevent adhesion formation at the incision site is of paramount importance, as it can enhance post-operative recovery and improve patient outcomes.

	●	Anti-Inflammatory Properties: CXCL12 possesses anti-inflammatory properties, which further contribute to its efficacy in inhibiting adhesion formation. Inflammation plays a crucial role in the development of fibrosis and adhesions. By reducing inflammation, CXCL12 helps create a more favorable environment for healing and tissue regeneration, minimizing the risk of adhesion formation.

	●	Fugetactic Properties: CXCL12 also exhibits fugetactic properties, meaning it can attract and guide cells away from the site of application. This property has been shown to be beneficial in preventing adhesions, as it directs cells to migrate away from the incision site, reducing the likelihood of tissue fusion and adhesion formation.

●	Our auditor has substantial doubts as to the Company’s ability to continue as a going concern.

●	We will need to obtain financing to implement our business plan.

●	We expect to continue to incur losses.

●	We remain a high-risk startup venture.

●	We are in the early stage of product development.

●	If our License Agreement with MGH is terminated, we will not be able to implement our current business plan.

●	Government regulation of our business is extensive and regulatory approvals are uncertain, expensive and time-consuming.

●	If the third-parties on which we may need to rely to conduct any future clinical trials and to assist us with pre-clinical development or other key steps do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for or commercialize our product candidates.

●	The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

●	We depend on our ability to protect our intellectual property.

●	If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

●	Third parties may claim that we infringe on their proprietary rights and may prevent us from commercializing and selling our products.

●	We may be subject to product liability claims that may not be covered by insurance and could require us to pay substantial sums.

●	We depend on key personnel.

●	Our operating results may fluctuate significantly as a result of a variety of factors, many of which are outside of our control.

●	We may be unable to manage rapid growth effectively.

●	The failure of government health administrators and private health insurers to reimburse patients for costs of our future products, or of services incorporating our future products, would materially and adversely affect our business.

●	If we are unable to successfully develop and market our products or if our products do not perform as expected, our business and financial condition will be adversely affected.

●	We face competition from established as well as other emerging companies, which could divert customers to our competitors and significantly reduce our revenue and profitability.

●	If we are unable to obtain adequate insurance, our financial condition could be adversely affected in the event of uninsured or inadequately insured loss or damage. Our ability to effectively recruit and retain qualified officers and directors could also be adversely affected if we experience difficulty in obtaining adequate directors’ and officers’ liability insurance.

●	Limitations on director and officer liability and our indemnification of our officers and directors may discourage stockholders from bringing suit against a director.

●	Our failure to manage growth effectively could harm our ability to attract and retain key personnel and adversely impact our operating results.

●	We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

●	The market prices and trading volume of our shares of common stock may experience rapid and substantial price volatility which could cause purchasers of our common stock to incur substantial losses..

●	An active, liquid and orderly market for our common stock may not develop, and you may not be able to resell your common stock at or above the public offering price.

●	The price of our common stock may be volatile, and you could lose all or part of your investment.

●	Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

●	If you purchase our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares.

●	Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.

●	We lack effective internal controls and procedures which could cause our investors to lose confidence in us and adversely affect the market price of our common stock and as a result of which we may not be able to accurately report our financial results or prevent fraud.

●	Substantial amounts of our outstanding shares may be sold into the market when lock-up or market standoff periods end. If there are substantial sales of shares of our common stock, the price of our common stock could decline.

●	If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

●	Failure to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause our financial reports to be inaccurate.

●	Our Board has the authority, without approval of the holders of our common stock, to issue preferred stock with terms that may not be beneficial to holders of common stock and with the ability to affect adversely stockholder voting power and perpetuate their control over us.

	●	being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus;

	●	not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”);

	●	reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

	●	exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Common stock offered by us		We are offering ______ shares of our common stock.

Offering Price		per share

Description of Representative Warrants		We have agreed to issue to the Representative, Representative Warrants to purchase up to a total of [ ] shares of common stock (equal to 5.0% of the shares of common stock sold in this offering). The Representative Warrants will be immediately exercisable from time to time, in whole or in part, commencing on the date of issuance until five years from the commencement of sales of this offering. The Representative Warrants are exercisable at a per share price of $[ ]. The Representative Warrants and the shares of common stock underlying the Representative Warrants are being registered hereby.

Common stock to be outstanding immediately after this offering		shares ( shares if the underwriters exercise their option in full).

Over-allotment option		We have granted the underwriters an option to purchase additional shares of common stock equal to 15% of the shares sold in the offering less the underwriting discounts and commission. This option is exercisable, in whole or in part, for a period of 45 days from the date of this prospectus.

Use of Proceeds		We estimate that the net proceeds to us from the sale of securities in this offering, after deducting underwriting discounts and offering expenses payable by us, will be approximately $ million. Our net proceeds will increase by approximately $ if the underwriters’ over-allotment option is exercised in full. We intend to use the net proceeds from this offering for product development, marketing and working capital and general corporate purposes. Additionally, we may use a portion of the proceeds to us for acquisitions of complementary businesses, technologies, or other assets. However, we have no commitments to use the proceeds from this Offering for any such acquisitions or investments at this time. See “Use of Proceeds.”

Reverse Stock Split		On _________, 2023, our stockholders approved a reverse stock split at a ratio of between 1-for 5 and 1-for-50, with discretion for the exact ratio to be approved by our board of directors. We plan to effect a 1-for-__ reverse split of our outstanding shares of common stock prior to effectiveness of the registration statement of which this prospectus forms a part. No fractional shares will be issued in connection with the reverse stock split and all such fractional interests will be rounded up to the nearest whole number of shares of common stock. The conversion and/or exercise prices of our issued and outstanding convertible securities, including shares issuable upon exercise of outstanding stock options and warrants, and conversion of our outstanding convertible notes will be adjusted accordingly. All information presented in this prospectus assumes a 1-for-__ reverse split of our outstanding shares of common stock, and unless otherwise indicated, all such amounts and corresponding conversion price and/or exercise price data set forth in this prospectus have been adjusted to give effect to the assumed reverse stock split.
Lock-up agreements		Our executive officers, directors and holders of more than 5% of the Company’s outstanding shares have agreed with the underwriters not to sell, transfer or dispose of any shares or similar securities for a period of 180 days from the date of this prospectus. For additional information regarding our arrangement with the underwriters, please see “Underwriting.”

Risk factors		See “Risk Factors” on page 13 and other information included in this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock.

Proposed Nasdaq Capital Market symbol		Our common stock is currently listed on the OTC (Pink Sheets) Market under the symbol “VICP.” We intend to apply to list our common stock on the Nasdaq Capital Market under the symbol “VICP”. No assurance can be given that our listing application will be approved. If our listing application is not approved by Nasdaq, we will not consummate this offering.

	●	[ ] shares of common stock reserved for future issuance under our 2022 Omnibus Equity Incentive Plan (the “2022 Plan”);

	●	[ ] shares of common stock issuable upon exercise of outstanding options with a weighted average exercise price of $[ ];

	●	[ ] shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $[ ]; and

	●	[ ] shares of common stock issuable upon exercise of warrants to be issued to the representative of the underwriters as part of this offering at an exercise price of $ .

	●	a 1-for- reverse stock split of our common stock effected on , 2023 pursuant to which (i) every shares of outstanding common stock was decreased to one share of common stock, (ii) the number of shares of common stock for which each outstanding option and warrant to purchase common stock is exercisable was proportionally decreased on a 1-for- basis and (iii) the exercise price of each outstanding option and warrant to purchase common stock was proportionally increased on a 1-for- basis (the “Reverse Stock Split”). No fractional shares were issued as a result of the Reverse Stock Split. Any fractional shares resulting from the Reverse Stock Split were [rounded up to the nearest whole share]; and

	●	no exercise by the underwriters of their option to purchase additional shares of common stock in this offering.

	Years Ended December 30,						Three Months Ended March 31,
	2022			2021			2023			2022
Revenues	$	—		$	—		$	—		$	—
Operating Expenses
Personnel costs		122.458			91,502			64,031			30,369
Research and development expenses, related party		13,097		$	17,698		$	10,000		$	10,000
Professional fees		448,506			191,881			133,483			113,885
Impairment loss		340,231			—			—			—
General and administrative expenses		60,198		$	35,790			3,763			12,793
Net loss	$	(984,790	)	$	(236,871	)	$	211,277		$	167,047
Net loss per common share – basic and diluted⁽¹⁾	$	(0.03	)	$	(0.01	)	$	(0.01	)	$	(0.01	)
Weighted average Common Shares outstanding – basic and diluted⁽¹⁾		30,577,988			17,656,762			34,585,742			28,712,656

	March 31, 2023
	Actual			As Adjusted⁽¹⁾⁽²⁾
Cash	$	4,140		$
Total assets		63,293
Total liabilities		1,204,664
Accumulated deficit		(15,325,692	)
Total stockholders’ equity (deficit)		(1,141,371	)

(1)	On an as adjusted basis to give further effect to (i) our issuance and sale of shares of common stock in this offering at an assumed public offering price of $ per share of common stock (which is based on the closing price of our Common Shares as reported by the OTCQB on , 2023), after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. As adjusted balance sheet data is illustrative only and will change based on the actual public offering price and other terms of this offering determined at pricing.

(2)	Each $1.00 increase (decrease) in the assumed public offering price of $ per share of common stock (which is based on the closing price of our Common Shares as reported by the OTCQB on , 2023) would increase (decrease) the as adjusted amount of each of cash, working capital, total assets and total stockholders’ equity (deficit) by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of shares of common stock in the number of shares of common stock offered by us at the assumed public offering price of $ per share of common stock (which is based on the closing price of our Common Shares as reported by the OTCQB on , 2023) would increase (decrease) the as adjusted amount of each of cash, working capital, total assets and total stockholders’ equity (deficit) by approximately $ million. These unaudited adjustments are based upon available information and certain assumptions we believe are reasonable under the circumstances.

	●	require us to incur substantial litigation expense, even if we are successful in the litigation;

	●	require us to divert significant time and effort of our management;

	●	result in the loss of our rights to develop, make or market our products; and

	●	require us to pay substantial monetary damages or royalties in order to license proprietary rights from third parties or to satisfy judgments or to settle actual or threatened litigation.

	●	the announcement or introduction of new products by our competitors;

	●	our ability to upgrade and develop our systems and infrastructure to accommodate growth;

	●	our ability to attract and retain key personnel in a timely and cost-effective manner;

	●	technical difficulties;

	●	the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure;

	●	our ability to identify and enter into relationships with appropriate and qualified third-party providers of necessary testing, future clinical trials and manufacturing services;

	●	regulation by federal, state or local governments; and

	●	general economic conditions, as well as economic conditions specific to the pharmaceutical and healthcare industries.

	●	if our future market capitalization reflects trading dynamics unrelated to our financial performance or prospects, purchasers of our common stock could incur substantial losses as prices decline once the level of market volatility has abated;

	●	if the future market price of our common stock declines, purchasers may be unable to resell your shares at or above the price at which you acquired them. We cannot assure you that the market of our common stock will not fluctuate or decline significantly in the future, in which case you could incur substantial losses.

	●	actual or anticipated variations in our annual or quarterly results of operations, including our earnings estimates and whether we meet market expectations with regard to our earnings;

	●	our current inability to pay dividends or other distributions;

	●	changes in market valuations of similar companies;

	●	market reaction to any additional equity, debt or other securities that we may issue in the future, and which may or may not dilute the holdings of our existing stockholders;

	●	additions or departures of key personnel;

	●	actions by institutional or significant stockholders;

	●	short interest in our stock and the market response to such short interest;

	●	the dramatic increase in the number of individual holders of our stock and their participation in social media platforms targeted at speculative investing;

	●	speculation in the press or investment community about our company or industry;

	●	strategic actions by us or our competitors, such as acquisitions or other investments;

	●	legislative, administrative, regulatory or other actions affecting our business, our industry, including positions taken by the Internal Revenue Service (“IRS”);

	●	investigations, proceedings, or litigation that involve or affect us;

	●	the occurrence of any of the other risk factors included in this Registration Statement on Form S-1; and

	●	general market and economic conditions

	●	our inability to establish collaborations, if needed;

	●	our failure to commercialize our product candidates, if approved;

	●	additions or departures of key management personnel;

	●	unanticipated serious safety concerns related to the use of our drug candidates;

	●	introduction of new products and services offered by us or our competitors;

	●	announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

	●	our ability to effectively manage our growth;

	●	actual or anticipated variations in quarterly operating results;

	●	our cash position;

	●	our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

	●	publication of research reports about us or our industry, our product candidates in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

	●	changes in the market valuations of similar companies;

	●	changes in the structure of the healthcare payment systems;

	●	overall performance of the equity markets;

	●	sales of our common stock by us or our stockholders in the future;

	●	trading volume of our common stock;

	●	changes in accounting practices;

	●	ineffectiveness of our internal controls;

	●	disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

	●	significant lawsuits, including patent or stockholder litigation;

	●	general political and economic conditions; and

	●	other events or factors, many of which are beyond our control.

	●	our projected financial position and estimated cash burn rate;

	●	our estimates regarding expenses, future revenues and capital requirements;

	●	our ability to continue as a going concern;

	●	our need to raise substantial additional capital to fund our operation;

	●	our dependence on third parties;

	●	our ability to obtain the necessary regulatory approvals to market and commercialize our product candidates;

	●	the ultimate impact of the current COVID-19 pandemic, or any other health epidemic, on our business or the global economy as a whole;

	●	the results of market research conducted by us or others;

	●	our ability to obtain and maintain intellectual property protection for our current and future product candidates;

	●	our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;

	●	the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;

	●	the success of competing products and services that are or become available;

	●	our ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;

	●	the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our product candidates;

	●	market acceptance of our product candidates, the size and growth of the potential markets for our current product candidates and any future product candidates we may seek to develop, and our ability to serve those markets; and

	●	the successful development of our commercialization capabilities, including sales and marketing capabilities.

	●	on an actual basis;

	●	on pro forma basis, to reflect the sale by us of shares of common stock sold in our April 2023 private placement and .
	●	on an as-adjusted basis, to reflect the sale by us of shares of common stock in this offering, at a public offering price of $ per share, assuming the underwriters do not exercise their over-allotment option, and after deducting estimated underwriting discounts and commissions and other estimated offering expenses payable by us.

	●	shares of common stock reserved for future issuance under our 2022 Plan;

	●	shares of common stock issuable upon exercise of outstanding options with a weighted average exercise price of $ ;

	●	shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $ ;

	●	shares of common stock issuable upon exercise of warrants to be issued to the representative of the underwriters as part of this offering at an exercise price of $ .

Public offering price per share			$
Historical net tangible book value per share as of March 31, 2023	$
[Pro forma increase in net tangible book value per share attributable to the conversion of convertible promissory notes]	$
Pro forma net tangible book value per share as of March 31, 2023		$
Pro forma increase in net tangible book value per share attributable to new investors
Pro forma as adjusted net tangible book value per share immediately after this offering		$
Dilution per share to new investors in this offering		$

	December 31, 2022		December 31, 2021
Common stock to be issued		727,281		11,067,281
Stock options		2,670,000		1,900,000
Warrants to purchase common stock		—		4,060,060
		3,397,281		17,027,281

	(i)	We shall provide a detailed business plan and development plan by June 1, 2022. As of the date of this registration statement of which this prospectus forms a part, we have yet to submit the business and development plan and is negotiating the extension of this requirement with MGH.
	(ii)	We shall raise $2 million in financing by December 1, 2022. As of the date of this registration statement of which this prospectus forms a part, we have yet to raise $2 million and is negotiating the extension of this requirement with MGH.
	(iii)	We shall raise an additional $8 million in financing by December 1, 2023.
	(iv)	We shall initiate research regarding the role of CXCL12 in beta cell function and differentiation by January 1, 2023.
	(v)	We shall initiate diabetic non-human primate studies using cadaveric islets encapsulated in the CXCL12 technology by March 1, 2023.
	(vi)	We shall initiate research regarding other applications of the CXCL12 platform by June 1, 2023.
	(vii)	We shall initiate a Phase I clinical trial of a Product or Process by March 1, 2024.
	(viii)	We shall initiate a Phase II clinical trial of a Product or Process within thirteen (13) years from Effective Date.
	(ix)	We shall initiate Phase III clinical trial of a Product or Process within sixteen (16) years from Effective Date.

	(i)	We shall itself or through an Affiliate or Sublicensee make a First Commercial Sale within the following countries and regions in the License Territory within eighteen (18) years after the Effective Date of this Agreement: US and Europe and China or Japan.

	(ii)	Following the First Commercial Sale in any country in the License Territory, we shall itself or through its Affiliates and/or Sublicensees use commercially reasonable efforts to continue to make Sales in such country without any elapsed time period of one (1) year or more in which such Sales do not occur due to lack such efforts by us.

	(i)	Prior to the First Commercial Sale, we shall pay to Hospital a non-refundable annual license fee of ten thousand dollars ($10,000) by June 30, 2022, and on each subsequent anniversary of the Eighth Amendment Effective Date thereafter. The non-refundable annual license fee was paid on July 1, 2022.

	(ii)	Following the First Commercial Sale, Company shall pay Hospital a non-refundable annual minimum royalty in the amount of one hundred thousand dollars United States Dollars ($100,000) per year within sixty (60) days after each annual anniversary of the Effective Date. The annual minimum royalty shall be credited against royalties subsequently due on Net Sales made during the same calendar year, if any, but shall not be credited against royalties due on Net Sales made in any other year.

	●	T1D cases among African American children increased by 20% with 20.8 children diagnosed per 100,000
	●	T1D cases among Hispanic children increased nearly 20% with 16.3 per 100,000
	●	T1D cases among Asian / Pacific Island children increased 19% with 9.4 per 100,000
	●	White children are the slowest growing demographic with a 14% increase, yet remain the most impacted group with 27.3 T1D cases per 100,000

	●	ViaCyte Inc. develops human embryonic stem cells that differentiate into pancreatic progenitor cells. We believe they are one of our most significant and advanced competitors, as they announced on August 1, 2017 that the first patients have been implanted with the PEC-Direct™ product candidate, an islet cell replacement therapy in development as a functional cure for patients with T1D who are at high risk for acute life-threatening complications. ViaCyte has established a collaboration with W.L. Gore & Associates, the makers of Goretex to created devices for implantation and protection of transplanted islets. ViaCyte is currently recruiting for a Phase 1/II clinical trial (NCT03163511).

	●	Sernova Corp. is a microcap company trading on the Toronto, Canada exchange that has developed a macro-cell pouch system for encapsulating cadaveric (allo-) islets that is currently in a Phase 1/II clinical trial. In July 2019, Sernova reported interim analysis demonstrating the cell pouch transplanted with islet cells showed initial safety as well as key efficacy measures.

	●	Beta O2 Technologies Ltd. (Rosh-Haayin, Israel). A biomedical company developing an implantable device, the BetaAir, to encapsulate islet cells for the treatment of T1D. They are in the process of changing from a device that requires external infusion of oxygen into their encapsulation device containing islet cells. Last public information was in 2015. The current status of Beta O2 Technologies Ltd. is unclear.

	●	DefyMed (Strasbourg, France): Defymed was founded in 2011 to develop implantable bio-artificial medical devices for diverse therapeutic applications, with a first focus on T1D. The diabetes product, named MAILPAN® (Macro- encapsulation of PANcreatic Islets), is a result of work done by the Centre Europeen d’etude du Diabete (CeeD), STATICE and the Centre de Transfert de Technologies du Mans (CTTM). The Mailpan system which is still in preclinical development uses non-biodegradable, biocompatible membranes for selective diffusion of insulin and glucose while protecting implanted stem-cell derived beta cells.

	●	Sigilon Therapeutics is a discovery-based platform combines cell engineering and its proprietary Afibromer™ technology, a new class of implantable biomaterials that do not trigger fibrosis. The company will develop products that emerge from its discovery platform to treat serious hematologic, enzyme deficiency and endocrine disorders –including T1D. Sigilon partnered with Lilly on the T1D indication in April 2018 but no recent information is available on the status of the partnership.

	●	Novo Nordisk has a stem cell line that differentiates into beta cells and one of the largest diabetes franchises in the world. In collaboration with Cornell researchers they have developed a hydrogel-based nanofiber encapsulation device with macroscopic dimensions. Currently appears to be in pre-clinical development.

	●	Sanofi and Evotec formed a partnership to jointly develop a beta cell replacement therapy for the treatment of diabetes in a deal that could reach more than 300 million Euros in potential milestone payments. Evotec achieved a milestone in 2018 for a manufacturing process for generation of iPSC-derived beta cells including scale-up. Collaboration is still in the pre-clinical phase.

	●	Baxter Healthcare has been marketing Adept®, a liquid solution for adhesion reduction, for gynecologic laparoscopic adhesiolysis indications since 2006. Baxter’s Adept solution has been extensively studied and its ability to prevent adhesions is controversial. Baxter Healthcare also markets COSEAL®, a synthetic hydrogel used in patients undergoing cardiac or abdomino-pelvic surgery to prevent or reduce the incidence, severity and extent of postsurgical adhesion formation. In February 2020, Baxter acquired the Sanofi franchise for Seprafilm Adhesion Barrier, a mechanical bioresorbable adhesion barrier that is indicated for the reduction in the incidence, extent, and severity of postoperative adhesions in patients undergoing abdominal or pelvic laparotomy. While Seprafilm is regarded as an effective barrier, challenges with respect to placement remain and limit its widespread use.

	●	Gynecare Worldwide, a division of Ethicon, Inc., a Johnson & Johnson company, markets Interceed®, a sheet adhesion barrier similar in intended use to Seprafilm but is indicated only for selected open gynecological indications.

	●	FzioMed, Inc. has received CE Mark approval in the European Union for Oxiplex®/AP Gel, an adhesion barrier for abdominal/pelvic surgery, and is conducting a clinical trial in the U.S., which is expected to be completed by December 2020. Fziomed has announced a global distribution agreement with Ethicon for distribution of Oxiplex/AP Gel.

	●	Covidien introduced SprayShield®, an adhesion barrier used in abdominopelvic procedures, that is approved for sale in Europe. In 2013, Covidien sold the SprayShield product line to Integra Life Sciences.

	●	preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;

	●	submission to the FDA of an Investigational New Drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin;

	●	approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated, or by a central IRB if appropriate;

	●	performance of adequate and well-controlled human clinical trials to establish the safety, potency, and purity of the product candidate for each proposed indication, in accordance with the FDA’s Good Clinical Practice, or GCP, regulations;

	●	preparation and submission to the FDA of a Biologics License Application, or BLA, for a biologic product requesting marketing for one or more proposed indications, including submission of detailed information on the manufacture and composition of the product and proposed labeling;

	●	review of the product by an FDA advisory committee, where appropriate or if applicable;

	●	satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the product’s identity, strength, quality, and purity, and, if applicable, the FDA’s current good tissue practice, or CGTP, for the use of human cellular and tissue products;

	●	satisfactory completion of any FDA audits of the nonclinical study and clinical trial sites to assure compliance with GLPs and GCPs, respectively, and the integrity of clinical data in support of the BLA;

	●	payment of user fees and securing FDA approval of the BLA;

	●	compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, adverse event reporting, and compliance with any post-approval studies required by the FDA; and

	●	Preclinical Studies and Investigational New Drug Application.