Regenerative medicine · Soft tissue reconstruction
inSoma Bio
A liquid protein that sets into a scaffold at body temperature, injected together with a patient’s own liposuctioned fat. Eight federal awards paid for the animal work. The first study in people started in August 2025 and is now suspended.
An afternoon at the microscope
Stefan Roberts was a graduate student in Ashutosh Chilkoti’s lab at Duke, doing exploratory work on protein polymers, when he attached a fluorescent tag to his proteins and put them under a microscope.
“If you want to pinpoint the origin of inSoma, it was an afternoon where I decided to fluorescently label my proteins and look at them under a microscope,” he told Duke Capital Partners in 2024.
What he saw was not the smooth gel a synthetic polymer gives. It was a network, knitted into a pattern that looked like elastin, the disordered protein that makes skin and blood vessels springy. The material was a thin liquid at room temperature and a porous solid at body temperature. That switch became the product, and the work ran in Nature Materials in 2018.
The problem with fat
Fat grafting is one of the fastest growing procedures in plastic surgery. A surgeon liposuctions fat from one part of a patient and injects it into a defect left by a mastectomy, trauma or a birth difference. It is the patient’s own tissue, so there is no implant to reject.
Liposuction is also what breaks it. The shear forces liquefy the fat and destroy the structure that held it in shape, so a large share of the graft dies after reinjection. inSoma’s own grant applications set out the cost of that: patients rebuilding a breast after mastectomy need an average of more than two operations to finish, because there is never enough usable tissue in one pass.
Fractomer is meant to be the missing scaffolding. Cold, it mixes with the lipoaspirate as a fluid. Warm, inside the body, it assembles into a porous mesh that holds the fat where the surgeon put it and lets blood vessels grow in.
Three founders and a surgeon’s three minutes
Roberts defended his thesis in 2018 and stayed on through a Duke program that funds a year of what amounts to an entrepreneurial postdoc. In that year he found the third founder. Scott Hollenbeck was Director of Breast Reconstruction at Duke, and by Roberts’s account it took him three minutes with the material to say his field had a problem this could solve.
Chilkoti, who chairs biomedical engineering at Duke, is the chairman and has co-founded five companies, including PhaseBio and Isolere Bio. Hollenbeck moved to the University of Virginia and took office as president of the American Society of Plastic Surgeons on September 29, 2024, which puts a founder at the head of the specialty society the product is aimed at.
Grants first, equity second
The first federal money was an STTR from the National Cancer Institute in 2019. Seven more followed, from NCI, NIGMS, NIDDK, NINDS and the NSF, covering breast reconstruction, facial fat grafting, burns, organoid culture and nerve repair. The North Carolina Biotechnology Center added a $250,000 research loan and a $500,000 growth loan.
Equity came later and in small pieces. Four Regulation D offerings run from June 2020 to the present, and the SEC file shows twelve filings against them. The company went through Y Combinator in the Summer 2020 batch and announced a $2.5 million seed in November 2023. A round that opened in September 2025 is still open.
Into people, and then a stop
On August 11, 2025, the first Fractomer went into a healthy volunteer at Nucleus Network in Saint Paul, Minnesota. The design is modest by intent: an injection into abdominal fat, blood work over weeks, then the implant is cut out and read by a pathologist. Two participants were enrolled.
The registry update posted on June 26, 2026 changed the status to suspended. The reason given on the record is one line: “Investigation into mild/moderate delayed reactions.” The estimated primary completion date of December 22, 2026 has not been moved. No company statement about the pause has been published.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Founding science | Roberts, Chilkoti and co-authors, “Injectable tissue integrating networks from recombinant polypeptides with tunable order,” Nature Materials 17(12), 2018. Cited as reference 1 in the company’s own 2023 surgical abstract. | Public record |
| Preclinical results | Surgical abstract, 2023: 12 months in mice, 4 months in Yucatan minipigs. Reported vascularization with minimal fibrosis, and 50% less fat needed for the same graft volume at 6 months, with no necrosis in the combined grafts. | Public record |
| First in human study | NCT07151638, sponsor inSoma Bio. Started Aug 11, 2025 at Nucleus Network, Saint Paul. Actual enrollment 2. Randomized, open label, two arms. Outcomes are safety only, ending in biopsy and histology. | Public record |
| Study status | Suspended. Reason on the registry: “Investigation into mild/moderate delayed reactions.” Status verified June 2026, update posted Jun 26, 2026. | Differs from company framing |
| FDA status | No 510(k) and no PMA for inSoma Bio in FDA databases. The trial record flags the product as an FDA regulated device that is not approved. No IDE number is published. | Public record |
| Federal funding | Eight SBIR and STTR awards, 2019 to 2024, six Phase I and two Phase II. SBIR.gov totals $4,622,787. Counting NSF’s own figure of $1,673,065 obligated on award 2304430 lifts the federal total to about $5.32 million. | Public record |
| Equity raised | Four Regulation D offerings, twelve filings under CIK 0001814250, $6,885,796 sold in total as filed, most recently $2,689,372 of a $4,000,000 offering as of Jan 22, 2026. | Public record |
| Total capital claimed | A 2026 conference biography for the CEO cites “over $15M funding, including $6M in competitive SBIR/STTR funding.” Filings, award records and reported state loans account for about $13.0 million, about $5.3 million of it SBIR and STTR. | Claim above the record |
| Peer reviewed output | One PubMed hit for the company: a 2025 review of biomaterials for peripheral nerve repair in J Biomed Mater Res A, co-authored by Roberts and Chilkoti. No published human data. | Not found |
| Revenue or product sales | None found. The company calls Fractomer investigational. | Not found |
Read plainly: the preclinical package is deep for a company this size, and federal reviewers backed it eight separate times. What is not proven is the part that matters most. Two people have received this material, and the study that would say whether it is safe in humans is on hold while the sponsor looks into delayed reactions. Everything downstream rests on that answer.
What to watch
- Whether NCT07151638 resumes, is redesigned, or is withdrawn. The registry entry still carries a December 2026 primary completion date that the suspension makes hard to meet.
- Any published detail on the delayed reactions, in a registry update, a conference abstract or a company statement.
- A new or amended Form D. The offering that opened in September 2025 was $1.31 million short of its raised target at the January 2026 filing.
- Whether the company clarifies the funding total published in its CEO biography.
In their words
“If you want to pinpoint the origin of inSoma, it was an afternoon where I decided to fluorescently label my proteins and look at them under a microscope,”
Stefan Roberts, co-founder and CEO, Duke Capital Partners, 2024 · Interview
“I remember Stefan as an unusually focused and driven young man when I interviewed him for graduate school,”
Ashutosh Chilkoti, co-founder and chairman, Duke Capital Partners, 2024 · Interview
“Plastic surgeons have spent decades chasing down an effective way to fill defects caused by cancer, trauma, birth defects or the aging process,”
Scott Hollenbeck, MD, co-founder, Duke Capital Partners, 2024 · Interview
“biologic putty that surgeons can inject and then hand craft into defect-conforming shapes,”
Scott Hollenbeck, MD, on what Fractomer is close to becoming, Duke Capital Partners, 2024 · Interview
“These grants provide valuable non-dilutive capital and third-party validation of the importance and quality of the work my team is doing,”
Stefan Roberts, Duke Capital Partners, 2024 · Interview
“We’re honored to be part of a program with a proven track record of launching some of the most impactful Medtech startups in the world,”
Stefan Roberts, on joining MedTech Innovator, NCBiotech, July 2025 · Independent
“NCBiotech was an early supporter of inSoma and we have been impressed with the company’s focus and trajectory,”
Jason Doherty, PhD, senior director of investments, NCBiotech, July 2025 · Independent
“Investigation into mild/moderate delayed reactions.”
Reason for suspension, ClinicalTrials.gov NCT07151638, posted June 2026 · Public record
Related companies
Sources
- Public recordClinicalTrials.gov NCT07151638, First-in-Human Safety Study for Fractomer Biomatrix
- Public recordSBIR.gov company portfolio, inSoma Bio, Inc., eight awards
- Public recordNIH RePORTER, seven projects under inSoma Bio, Inc.
- Public recordNSF SBIR Phase II award 2304430
- Public recordForm D and Form D/A filings, inSoma Bio, Inc., CIK 0001814250
- Public recordRecombinant Elastin Biomatrix Improves Autologous Fat Grafting, abstract
- Public recordDesigning Next-Generation Biomaterials to Enhance Peripheral Nerve Repair and Reconstruction
- Public recordInjectable tissue integrating networks from recombinant polypeptides with tunable order
- InterviewHow Stefan Roberts and inSoma Bio are upgrading fat grafting with Duke technology and support
- IndependentThree Triangle MedTech startups score big with key accelerator
- IndependentBiotech Center Awards $2.3 Million in Grants, Loans in Latest Quarter
- IndependentDurham biotech startup inSoma Bio raises $202,000 in security
- IndependentMedTech Innovator 2025 Value Award finalists
- CompanyinSoma Bio website, home, technology and news archive
- CompanyinSoma Raises $2.5M in Seed Round
- CompanyStefan Roberts speaker biography
- CompanyinSoma Bio company profile
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
