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Pioneering Automatic Dry Precision

Warming and Thawing of Plasma,

Cell and Gene Therapies and Biologics

Up to $7.55mm of Preferred Stock with Warrants

sleeve

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Industry

Medical Devices

Company Type

Venture Generating Revenue

Size

$15 Million

Investment Type

Equity

Revolutionizing Life-Saving Plasma Therapies

MARKET

Annually, millions undergo vital procedures relying on accurately thawed pre-frozen plasma, addressing surgical, trauma, and chronic condition needs

PROBLEM

Current thawing approaches grapple with imprecision, significant waste, bacterial contamination, and stark design inadequacies

SOLUTION

FMS has pioneered the only FDA-approved universal thawing/warming platform, innovatively eradicating historic shortcomings and propelling plasma therapies into a new era

FMS Early Milestone:

Used in 100+ healthcare facilities

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Current tech in 1+ million healthcare facilities:

“like putting a hot dog in hot dog water”

Positioned to Lead the Global Precision Thawing and Warming Revolution

FMS is raising up to $15mm of preferred equity to accelerate sales growth globally, implement next generation product initiatives and extend its attackers advantage in the blood products, biologic and cell and gene therapy thawing/warming markets.

ZipThaw and ZipSleeve have no comparable and only FDA cleared universal platform for precision dry warming and thawing of blood products, tissue, mother’s milk, and related biologics, human or animal


FMS have sold over 275 devices, and installed in 100 locations for the military (both land and vessel), major hospital systems, research facilities, community hospitals, the government and internationally


Management believe there are no visible competitors in the FDA pipeline, they have a significant time and market position advantage and Zip Thaw and ZipSleeve are the gateway to cell and gene therapy products.


Founded and managed by distinguished medical industry professionals and veterans who experienced firsthand the large need for this product


Q4 2023 estimated ~$700,000 of revenue; sales purposefully slowed to a crawl during COVID, and restarted in Q3 2022; Company expects revenues to grow rapidly

A Global Opportunity: Perfect Timing

Millions of life-saving surgical, trauma, rare diseases and chronic condition procedures are performed each year requiring the use of pre-frozen blood plasmas which must be thawed to precise metrics before transfusion


There has been no innovation for decades from the current water bath/tank systems; Water bath systems are plagued by lack of precision, waste, bacterial cross-contamination, and design limitations


There were no cell and gene therapy applications to the FDA five years ago


Today, cell and gene therapy is accelerating

Simon Alfano, an associate partner at McKinsey & Company, said he has noticed a significant increase in the number of cell and gene therapies in clinical development over the past decade; “There are currently more than 1,000 cell and gene therapies in clinical development in the U.S., with more than 3,000 in pre-clinical development,” Alfano told BioSpace “Based on past clinical attrition rates,” he continued, “this level of clinical activity suggests an acceleration of new cell and gene therapy launches towards the second half of this decade”

FMS’s Solution – Legacy Systems vs. ZipThaw Wins

Water bath/tank-based:

  • Contamination risks
  • Water spills
  • Weekly required decontamination
  • Non-precise
  • High use and maintenance costs
  • Toxic chemicals

ZipThaw:

  • Reduced Risk of Contamination to patients
  • No decontamination cleaning
  • Precise
  • Dry and Portable
  • Easy to use
  • Lower use and maintenance costs
  • No toxic chemicals

Partnerships, Regulatory Approvals, and Registrations

Manufacturing and other partners

  • ZipThaw: Minnetronix Medical, MN
  • ZipSleeve: Boyd Technologies, MA
  • Fulfillment and Logistics: Navis, MN

Regulatory approvals

  • FDA cleared 2019
  • AABB Compliance Standards Certification
  • CE Mark/ISO 13485 certification
  • UL certification and registration
  • EMC/Safety/Radio certification to IEC 601- 1/EN60601-1, AMD1:2015 2019
  • ISO Certification

Registrations – “Sales Channels”

  • GSA General Services Administration
  • Federal Supply Classification ID # NSN 6640-01-696-4025
  • ECAT – U.S Defense Logistics Agency Troop support Medical Supply Chain Electronic Catalog
  • AMAL – allows any ship captain to directly purchase from GSA/ECAT: Management estimates it took at least 18 months to achieve

Management

Farideh Z. Bischoff, Ph.D.

Chief Executive Officer, Chief Scientific Officer and Board of Directors (Joined February 2019)

Farideh received her Ph.D. in Cancer Biology with Honors from University of Texas Graduate School for Biomedical Sciences (Houston, TX) followed by postdoctoral training at M.D. Anderson Cancer Center and Baylor College of Medicine. She is clinically trained and a recognized expert in human molecular genetics and cytogenetic; and has served as a full-time professor in the Department of Obstetrics and Gynecology at Baylor College of Medicine. She has consulted for the FDA and major pharmaceutical companies on the safety and efficacy of rare cell and liquid biopsy testing worldwide. With over 300 papers/chapters published and 12 Patents, Farideh has made significant contributions to the research and clinical fields of prenatal diagnosis, oncology, infertility and preimplantation genetic diagnosis.   Commercially, Farideh led, clinical validation and commercialization of multiple clinical diagnostic assays currently used today as liquid biopsy oncology tests offered by Biocept, Inc. (NYSE: BIOC).

Frederick J. Thacher

Co-Founder, Chief Development Officer, and Director

Fred has 25+ years of medical service and device experience where he developed and expanded specialty health facilities in the US and Europe. He served as Director of Marketing and Business Development at AliMed Corp. where he reorganized operations and increased sales to $90+ million. He was Manager of International Business Development at Thermogenesis Corp. where he built and serviced a distribution network of partners in the EU, Middle East, Asia and Africa, increasing sales by 200%. He has a B.S. degree from Boston University, a Certificate in Finance from Stanford University, and a Certificate in Planning from the Wharton School. Fred is a veteran and has been awarded a Bronze Star, a Purple Heart, and an Air Medal.

Moni Shavit

Co-Founder, Chief Technology Officer, and Director

Moni has 25+ years of experience in business and technology development, marketing, R&D, engineering of systems and medical devices. Moni has held positions as VP of R&D at ThermoGenesis Corp., Sr. Director of engineering at BioGenics Corp.; VP of R&D and VP of Business Development at MediVision Medical Imaging systems; and VP of R&D at AFP Imaging Corp. Moni is an author and co-author of several patents in medical devices and is credited with the development of more than 20 medical devices in imaging, blood banking, and cardiovascular clinical use. Moni earned his M.Sc. and B.Sc. degrees in electronics from the Polytechnic Institute of New York University.

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Thanks, Ken

Ken Margolis | Managing Partner Castle Placement, LLC
1460 Broadway Street, Rte 400
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