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Industry

Healthcare

Company Type

Biotechnology/Life Sciences

Size

$6 Million

Investment Type

Equity

For additional information, please contact:
Gary Levy | Managing Director
(516) 457-0104

Veige in a Nutshell

  • An estimated 32 million women in the USA alone suffer from Vulvovaginal Atrophy (VVA) also known as Atrophic Vaginitis, an acutely painful condition affecting vaginal and vulval tissue

 

  • The FDA has required that all currently approved estrogen products include a “Black Box” warning regarding cardiovascular and cancer risks

 

  • Veige is developing an alternative that is effective, safe, and available over the counter

 

  • Women’s healthcare is changing, now

Overview

  • Veige Healthcare is raising $6 million (excluding $1.5 million already raised) to complete their novel solution for VVA, an enormous medical problem

 

  • This disease affects women with reduced estrogen levels (hypoestrogenemia) and results in irritated, dry and inflamed vaginal tissue impacting to varying degrees the quality of life for over 64 million post-menopausal (PM) women in the US today, with one million new sufferers annually

 

  • Over 75% of PM women report that VVA is a significant factor in reducing life quality. Furthermore, due to women’s reticence to discuss these issues, incidence is dramatically under reported and under diagnosed. Current treatments rely on hormone replacement therapy (HRT) with significant health risks, with the FDA requiring a “Black Box” warning on all estrogen products – leaving a massive opportunity for a safe therapy

Opportunity

  • The global VVA therapy market was $2.22 billion in 2023. In 2024 the market size is assessed at $2.44 billion, and is set to reach $8.41 billion by the end of 2036, registering an approximate 10.8% CAGR

 

  • The US VVA treatment market, amongst markets worldwide, is projected to hold the largest market share by the end of 2036. Market size was valued at $1.15 billion in 2023. The market is projected to grow from $1.19 billion in 2024 to $1.63 billion by 2032 (4.1% CAGR)

 

  • Growing concerns regarding the side effects of estrogen-based therapies are propelling the preferential shift toward non-estrogen-based treatments for VVA

 

  • Veige Healthcare asserts that the only approved treatment currently available for this serious problem is Hormone Replacement Therapy (HRT), which use estrogen or modify the estrogen pathway

 

  • HRT is helpful in reducing VVA symptoms in about 75% of PM patients; approximately 25% of women are non-responders

 

  • The FDA has determined that HRT also causes a significant increase in the incidence of cardiac events, dementia, stroke, deep vein thrombosis and cancer, requiring a Black Box warning label on all estrogen-containing products, emphasizing the significant health risks

Solution/Strategy

  • Izun Pharmaceuticals has developed a patent protected treatment for VVA, without the associated health risks – Veige Healthcare has the exclusive worldwide IP licensing agreement in perpetuity to use this technology

 

  • This topically applied treatment is based on many years of research into the biologically active components, found in specific botanicals, that have been patented and combined in a formulation designed to maximize the therapeutic effect while ensuring a strong safety profile

 

  • FDA 510(k) clearance pathway identified, w/projected timeline of Q3 2025

Competitive Advantage

  • Non-hormonal approach: safe for all women, including those with a history of breast cancer

 

  • Clinically proven efficacy: significant symptom reduction and tissue repair

 

  • Patent-protected technology in over 18 countries

 

  • DTC channel & digital marketing

 

  • Experienced leadership team

Actual Repair

All other non-estrogen-containing products on the market have a moisturizing and lubricating action only, whereas Veige actually repairs the vaginal tissue.

Pathway to Market

FDA Clearance

 

  • The Veige product for the VVA indication is expected to be cleared as a Medical Device via the 510(k) FDA registration process

 

  • Veige has sufficient robust clinical trial data to support strong claims and product differentiation

 

  • Projected FDA clearance: Q3 2025

 

  • In addition, Veige is planning an additional trial, post-FDA clearance, to enhance therapeutic claims and strengthen the professional acceptance of this product

Experienced Executive Leadership Team

Jonathan Kalman

CEO

  • Serial entrepreneur, with track record of launching, building, and selling successful businesses
  • Early investor and board member across early-stage technology companies with a focus on biopharma and medical devices
  • Three successful M&A transactions to international corporations for amounts ranging from $70M to $1.1B

Dr. William Levine

CSO

  • DDS degree with specialty training in Periodontics from Columbia University
  • Founder of Izun Pharmaceuticals, a biopharmaceutical company specializing in Botanical-based Medicine
  • Diplomate of the American Board of Periodontology
  • Member of Scientific Board of companies focused on Robotic Surgery and Oral Diagnostic technologies

Les Kraus

CFO

  • CPA with 40+ years of operational and financial experience covering industrial, retail and wholesale businesses
  • Former CFO of Australia’s largest menswear retailer, where he managed two sale processes to private equity firms

Dr. Amy Rosenbluh

Director of Production & Laboratory Manager

  • Master’s degree from Harvard University and Ph.D. from Tel Aviv University, with post-doctoral fellowships at both Stanford University and the Weizmann Institute
  • Vast experience in research and management, both in academia and the private sector

Advisory Board

Robin Kroll, MD

Recognized leader in women’s healthcare. Board-certified Gynecologist and Menopause Clinician with special interests in contraception, menopause, and sexual dysfunction. Medical Director Emeritus of Women’s Clinical Research Center where she now serves as Consultant/Advisor. Member of numerous professional societies and has been selected by her peers to be included in Best Doctors™ and has been named in “Top Doctors” by Seattle Magazine. Has served as a principal investigator for over 300 clinical trials in the field of women’s health and publishes frequently in peer reviewed journals. 

Dr. Brian Bernick

Multidimensional healthcare executive and entrepreneur with 30 years of clinical medicine experience, primarily in women’s health. Founded a women’s health company responsible for 3 FDA new drug approvals and a pharmaceutical company exclusively committed to advancing the health of women. Recognized by colleagues as one of the leading practitioners of obstetrics & gynecology and has over 100 peer-reviewed publications and presentations of original research and over 70 US and foreign patents focusing on drug therapies and analysis.

Prof. Gabriel Nussbaum

Physician researcher and a tenured full professor in the Institute for Biomedical and Oral Research of the Hebrew University of Jerusalem. Began research career as an MD, PhD student at the Albert Einstein College of Medicine and did  postdoctoral work at the Weizmann Institute of Science. Trained in internal medicine and conducts research at the interface of inflammation, the host response to microbial pathogens, and cancer.

Specific Risks

  • Failure to obtain FDA 510 (K) clearance

 

  • Delay in product launch

 

  • Inability to reach projected sales and revenue forecasts

 

  • Entry into the market of another non-Estrogen product with similar efficacy

 

  • Challenge of building top tier marketing team

 

  • Private securities are speculative, illiquid, and carry a high degree of risk – including the loss of the entire investment
Learn More About Veige Healthcare

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Thanks, Ken

Ken Margolis | Managing Partner Castle Placement, LLC
1460 Broadway Street, Rte 400
New York, New York 10036
(212) 418-1188 | C: (516) 712-7784
kmargolis@castleplacement.com

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