Sofregen Medical

What Sofregen Medical does

Sofregen Medical Inc. is a privately held, venture-backed biotechnology company founded in 2014 to commercialize silk protein (fibroin) biomaterial technology developed at Tufts University and the University of Pittsburgh. The company is headquartered at 175 Crossing Boulevard, Suite 510 in Framingham, Massachusetts (with a Cambridge, MA mailing footprint and a Privacy Office in Medford, MA), and operates with 11–50 employees. Its proprietary platform transforms purified silk fibroin into liquid silk and porous silk particles that can be combined with carriers such as hyaluronic acid to produce injectable implants and implantable scaffolds for soft tissue support and regeneration.

Sofregen's commercial product is Silk Voice®, an FDA 510(k)-cleared (K180631) silk protein injectable implant for vocal fold medialization and vocal fold insufficiency — the first and only FDA-cleared product made from solubilized silk protein. The product is sold as a kit of two prefilled syringes with a single-use flexible catheter delivery system, targeting trained otolaryngologists and head and neck physicians performing office-based procedures. U.S. distribution runs exclusively through PENTAX Medical under an October 2020 agreement. The company historically sold SERI® Surgical Scaffold — a silk-based surgical implant acquired from Allergan PLC in 2016 — but discontinued it as of December 31, 2021. Sofregen is also developing silk-based biostimulator fillers and next-generation biological scaffolds for facial aesthetics and reconstructive surgery.

The company's revenue model rests on two pillars: hardware sales of Silk Voice kits through PENTAX Medical, and a co-development and option-to-acquire partnership with Galderma (announced September 2021) covering next-generation biostimulator fillers and granting Galderma an exclusive option over Sofregen's Silk Voice and aesthetics assets. Sofregen has raised approximately $15.8M in cumulative funding ($1.6M seed, $6.2M Series A in 2016 led by Polaris Partners, and $8M Series B in 2019 led by Anzu Partners, plus $3.5M in bank debt). Leadership comprises Co-founder and Executive Chairman Howard J. Weisman, Co-founder and CSO Anh Hoang, and CEO Jonathan T. Hartmann (appointed December 2019).

Name

Sofregen Medical

Legal name

Sofregen Medical Inc.

Website

https://sofregen.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Sofregen Medical is a privately held biotechnology company developing purified silk protein (fibroin) biomaterials for soft tissue regeneration. Its FDA-cleared Silk Voice® injectable treats vocal fold insufficiency, while pipeline biostimulator fillers target aesthetic applications under a Galderma partnership.

Ownership category

akta.pro rank

Product category

Soft Tissue Regeneration Medical Devices

NAICS

Artificial and Synthetic Fibers and Filaments Manufacturing (32522)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG)

akta.pro secondary industry

3D Bioprinting & Biofabrication (HLAAAGAC)

Keywords

• Silk protein implants
• Soft tissue regeneration
• Vocal fold treatment
• Silk fibroin biomaterials
• Injectable tissue bulking

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Operations, Others

Revenue model

1. Silk Voice Product Sales: Sale of Silk Voice injectable implant kits containing prefilled syringes and single-use catheter delivery systems to otolaryngologists and head and neck physicians for vocal fold medialization procedures.
2. Co-development and Licensing Revenue: Co-development activities with Galderma for next-generation biostimulator fillers, with potential option-to-acquire agreement for aesthetic business assets.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Sofregen Medical develops and commercializes medical devices based on a proprietary purified silk protein (fibroin) biomaterial platform for soft tissue regeneration. Its commercial product is Silk Voice® Injectable Implant, an FDA 510(k)-cleared silk protein and hyaluronic acid combination injectable indicated for vocal fold medialization and vocal fold insufficiency. The company also pursues co-development of next-generation biostimulator fillers for aesthetic use through a partnership with Galderma.

Product overview

Sofregen Medical is a pioneer in soft tissue engineering with an advanced platform based on purified silk protein (fibroin). The company offers Silk Voice® Injectable Implant as its primary FDA-cleared commercial product for vocal fold medialization. The portfolio includes Silk Voice® (silk protein particles with hyaluronic acid carrier for tissue bulking), discontinued SERI® Surgical Scaffold (silk-based surgical implant), and pipeline products including silk-based biostimulator fillers and biological scaffolds in development for aesthetic and reconstructive applications.

Differentiator

Problem solved

Functional benefit

Brands

• Silk Voice®: FDA-cleared silk protein injectable implant for vocal fold medialization and vocal fold insufficiency.
• SERI® Surgical Scaffold
• Silk Protein Platform

Products and services

• Silk Voice® Injectable Implant FDA 510(k)-cleared silk protein injectable implant indicated for vocal fold medialization and vocal fold insufficiency. Combines silk protein particles with a hyaluronic acid carrier to provide immediate volume restoration that is gradually replaced by healthy tissue through cellular infiltration into the silk scaffold. Kit contains two prefilled syringes and a single-use flexible catheter. Sold to trained otolaryngologists and head and neck physicians for office-based procedures.
• SERI® Surgical Scaffold (Discontinued) Silk-based implantable biological scaffold originally FDA cleared in 2013. Multifilament biomaterial providing soft tissue support and regeneration. Acquired by Sofregen from Allergan PLC in late 2016 and commercially discontinued as of December 31, 2021.

Quantifiable outcome

• Silk Voice projected to last more than 12 months with slow absorption profile
• +2 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered flagship, core and minor.

• GaldermaflagshipStrategic or Co-development Partner · 23 September 2021Co-development and option-to-acquire agreement for next-generation biostimulator fillers using silk-based technology. Galderma, the world's largest independent dermatology company, will co-develop a portfolio of novel silk-based biostimulator fillers and has an exclusive option to acquire Sofregen's Silk Voice and aesthetics business assets.
• PENTAX MedicalcoreChannel Partner/ Reseller/ Distributor · 28 October 2020Exclusive U.S. sales agent agreement for Silk Voice Injectable Implant. PENTAX Medical, a healthcare industry leader in diagnostic and therapeutic endoscopy solutions, serves as the exclusive distributor for Silk Voice in the United States, accelerating patient access to the innovative vocal fold treatment.
• Tufts UniversitycoreStrategic or Co-development PartnerTechnology origin for silk protein platform. Founded in 2014 to advance technology developed at Tufts University's Biomedical Engineering Department.
• University of PittsburghminorStrategic or Co-development PartnerCo-origin of silk protein technology. Sofregen was founded to advance technology developed at Tufts University and the University of Pittsburgh.
• AllerganminorOthersSofregen acquired SERI Surgical Scaffold from Allergan PLC in late 2016. SERI was the first and only surgical implant made from silk fiber.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Galderma: The world's largest independent dermatology company and Sofregen's co-development partner; markets Restylane, Sculptra, and other biostimulator/filler products and has an option to acquire Sofregen's aesthetics assets, making it both collaborator and most direct competitive threat in aesthetics.
• Revance Therapeutics: Aesthetic-focused biopharmaceutical company developing and commercializing injectable products (e.g., DAXXIFY, RHA Collection fillers); comparable in size and stage, targeting the same dermatology and plastic surgeon customer segments.
• Evolus: Aesthetic injectable company focused on Jeuveau (prabotulinumtoxinA); operates with a focused commercial model targeting the same aesthetic practitioners and is at a similar lifecycle stage of scaling a single-product aesthetics franchise.
• Collagen Solutions: Supplier of collagen-based and other natural biomaterials for medical devices, tissue engineering, and regenerative medicine; comparable as a niche biomaterials platform company targeting soft tissue repair and regenerative applications.

Broad incumbents

• Allergan Aesthetics (AbbVie): Markets Juvederm and other leading hyaluronic acid and biostimulator fillers; previously owned the SERI Surgical Scaffold that Sofregen acquired in 2016, and represents the dominant aesthetic injectable competitor Sofregen's pipeline must displace.
• Merz Aesthetics: Global aesthetics incumbent marketing Radiesse (CaHA), Belotero, and Xeomin; competes head-to-head against Sofregen's pipeline biostimulator fillers and serves the same dermatology/plastic surgery customer base.
• Integra LifeSciences: Public regenerative medicine and surgical implant company with a portfolio that historically included silk-based scaffolds; overlaps directly with Sofregen's surgical scaffold heritage (SERI) and broader soft tissue regeneration strategy.

Emerging players

• Establishment Labs: Aesthetic implant company developing Motiva breast implants and related biomaterial devices; comparable as a niche premium aesthetics player competing against large incumbents with differentiated biomaterial technology.
• Sientra: Aesthetics company commercializing breast implants and biologic tissue matrices; comparable as a small-cap aesthetics device company competing against large incumbents with differentiated biomaterials.
• Tela Bio: Commercial-stage regenerative medicine company developing soft tissue reconstruction matrices (OviTex, Artia) from biologic and synthetic materials; competes in adjacent soft tissue repair indications with a similar small-cap profile.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/9334962
• Xx.com/SofregenMedical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sofregen Medical