Medical devices & diagnostics · Surgical adhesions
TYBR Health
A pourable gel made from cow bone that surgeons spread over a fresh tendon repair so scar tissue cannot glue it in place. Cleared by the FDA in June 2025, used in a US operating room for the first time in January 2026, funded with $30 million in July 2026. The efficacy data so far comes from rabbits.
An aunt, a hammer and a coffee grinder
Tim Keane is one of seven children. “A big family was important to my sisters and my aunts and my uncles,” he told Texas Medical Center News in 2020.
In 2016 his aunt Jackie wanted more children. Over three years each pregnancy ended in miscarriage. Her doctors traced the cause to adhesions left by an earlier cesarean section: bands of scar tissue that form as the body repairs itself, and that do not know where one organ ends and the next begins.
“A lot of women, after they have a C-section once, the next time they get pregnant, they’re going to have a C-section again because of adhesions,” Keane said. “That’s what happened with her.”
Three years later he was in Houston on a device fellowship, shadowing surgeons across the Texas Medical Center. The first version was cooked in bench space at JLABS: bovine tibia chopped into chunks, the spongy bone at the center pounded out with a hammer from Walmart, decellularized, stripped of calcium, ground in a Walmart coffee grinder, digested with pepsin. Warmed to body temperature, the liquid sets into a film over whatever it was poured on.
The thing every surgeon steps around
Adhesions are close to universal. They form in more than nine of every ten people who have open-abdomen surgery, and in 55 to 100 percent of patients after gynecologic surgery, per figures Texas Medical Center News attributed to the NIH. In the hand, where TYBR landed, the company cites estimates that up to 40 percent of tendon repair patients keep a lasting mobility limit.
Barriers exist for this, and they are sheets: thin films laid between tissue surfaces so repair cells cannot bridge them. They work in an open belly and are awkward everywhere else. Co-founder Alex Smith put it in a line: “It’s like trying to place saran wrap with tweezers.” A gel goes where a sheet will not. That is the pitch.
Two engineers and a medical student
Keane holds a PhD in bioengineering from the University of Pittsburgh, was an NSF Graduate Research Fellow, and went to Imperial College London as a Marie Skłodowska-Curie Fellow and Whitaker International Scholar before a device Biodesign fellowship at the Texas Medical Center in 2019. His subject throughout was extracellular matrix, the scaffold that surrounds cells.
P. Alex Smith has a BS and MEng from Texas A&M and a PhD in mechanical engineering from the University of Houston, with a decade of device work on dialysis access, vaginal dilators and ventricular assist pumps. He is CTO.
There was a third. Stephen Ramon, then a medical student at the University of Virginia, is named with Keane and Smith in the 2020 account of the founding and appears as an executive officer on the first Form D that December. He is on no filing since.
From the belly to the hand
The early federal money went to the abdomen: three NIH Phase I grants worth $782,475 in 2021 and 2022, two on bowel and colorectal work, one on tendon surgery. Y Combinator took the company into Winter 2022 and still describes it, in 2026, as a hydrogel “to keep internal organs scar-free after surgery.”
The product that reached the market is orthopedic. The FDA received the submission on January 16, 2025 and cleared it on June 6, 2025. On the FDA record the device is TYBR Collagen Gel; the company sells it as the B3 GEL System, dyed blue so a surgeon can see where it went.
Then the pace picked up. September 4, 2025: first patients in an Australian study of the gel in tenolysis, the operation done to cut a tendon free of scar already holding it. January 5, 2026: first US use, three flexor tendon cases by one surgeon in Lubbock, Texas. January 12, 2026: Jeff Tyber of Tyber Medical joins the board. July 21, 2026: $30 million led by Vensana Capital and Mutual Capital Partners.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K250109 | Received Jan 16, 2025, decision Jun 6, 2025, Substantially Equivalent, Traditional 510(k). Device name on the record: TYBR Collagen Gel. Regulation 878.3300, Class II, listed as implanted. The 510(k) summary was not retrievable at the FDA document path on Sep 21, 2026, so the cleared indications wording is not in hand. | Public record |
| What the code covers | Product code OWY is a collagen surgical mesh defined as “For reinforcement of soft tissue where weakness exists in tendon repair.” No FDA record grants TYBR an adhesion prevention claim, an abdominal indication or a laparoscopic one. | Public record |
| Tendon data, peer reviewed | Rabbit flexor tendon model, Plastic and Reconstructive Surgery, Mar 11, 2026, TYBR authors with University of Virginia, Stanford and UTHealth Houston. Range of motion 70.4 and 69.8 degrees treated against 50.7 in saline controls; adhesion score 5.2 against 8.0; no effect on rupture strength. Animals and cadaver tendon, not patients. | Public record |
| Abdominal data, peer reviewed | Mouse and rabbit colorectal and gynecologic models, Science Translational Medicine, Oct 8, 2025, TYBR authors with groups in Madrid and at Imperial College London. Reduced adhesion severity, mesothelial lining preserved. Preclinical, and in an area the cleared device does not cover. | Public record |
| Human study | Multicenter Australian study in flexor and extensor tendon tenolysis, first patients announced Sep 4, 2025, principal investigator Professor Randy Bindra, Gold Coast University Hospital. No results as of Sep 22, 2026. | Company-stated |
| Trial registration | No registry entry for that study was located, and no registration number appears in any release. | Not found |
| First US cases | Three cases by one hand surgeon in Lubbock, Texas, announced Jan 5, 2026. The release names him Hanna Tammam; InnovationMap gives Tammam Hanna, at Texas Tech University Health Sciences Center. Outcomes surgeon-reported, no follow-up given. | Company-stated |
| Company efficacy figures | The research page headlines “50.4° ROM vs. 34.3° in controls” and a 35 percent adhesion reduction, both marked “Data on File - under review for publication”. The adhesion numbers match the published rabbit study exactly. The range of motion numbers do not. | Differs from the paper |
| Strength of the claim | The website tells surgeons they have reviewed the “clinical evidence that proves it works”. No human outcome data for the gel had been published anywhere as of Sep 22, 2026. | Claim exceeds the record |
| Federal grants | Three NIH SBIR Phase I awards totaling $782,475: R43DK127897, R43DK133012 and R43AR079966. No NSF award to the company was found. | Public record |
Read plainly: TYBR has a cleared, sellable orthopedic device, two peer-reviewed animal studies pointing the same way, and a first human study with no reported results. A 510(k) shows a device resembles one already sold; it does not show patients move better afterward. The rabbit numbers are encouraging and the mechanism work is careful. Neither is a human outcome, and the marketing has run ahead of that on two counts.
What to watch
- Results from the Australian tenolysis study, and whether a registry entry for it ever appears.
- Whether the range of motion figures on the company site reach peer review.
- A second FDA submission. An adhesion prevention claim or an abdominal indication needs one.
- Whether the abdominal program behind the NIDDK grants and the 2025 paper returns as a product.
- Named hospital accounts and any revenue figure.
In their words
“It’s just, to me, mind-boggling that a surgery that is done to either fix a problem or to do a routine procedure, is something that can cause lifelong complications for a person.”
Tim Keane, co-founder and CEO, TMC News, 2020 · Independent
“It’s like trying to place saran wrap with tweezers.”
Alex Smith, co-founder, TMC News, 2020 · Independent
“In almost every tissue in the body, and every disease you can think of, there’s some aspect of scarring that affects the lives of millions and millions of people.”
Tim Keane, TMC News, 2020 · Independent
“Too often, healing goes unprotected once the procedure ends.”
Tim Keane, FDA clearance release, June 2025 · Company release
“Adhesions remain a major driver of stiffness and reoperation after flexor tendon repair.”
Professor Randy Bindra, Gold Coast University Hospital, September 2025 · Company release
“The gel set within minutes, maintained excellent visualization, and allowed smooth tendon gliding without restricting motion.”
Hanna Tammam, MD, hand surgeon, January 2026 · Company release
“Surgeons are exceptionally good at the structural repair, but the biology that follows is what determines how it heals.”
Tim Keane, Series A release, July 2026 · Company release
Related companies
Sources
- Public record510(k) database record K250109, TYBR Collagen Gel
- Public recordProduct classification, code OWY
- Public recordFlowable ECM hydrogel to prevent adhesion after flexor tendon repair
- Public recordSprayable ECM hydrogel reduces postoperative adhesion formation
- Public recordNIH RePORTER R43DK127897, R43DK133012, R43AR079966
- Public recordForm D and Form D/A filings, CIK 0001835188
- IndependentInventing a new goo to prevent scarring
- IndependentFDA clears TYBR Health’s gel system for preserving mobility post-surgery
- IndependentHouston healthtech startup raises $30M to scale surgical healing gel
- IndependentMedtech Startups tracker entry
- IndependentKeiretsu Forum investor session listing
- CompanyFDA 510(k) clearance for B3 GEL System
- CompanyFirst patients enrolled in tendon surgery trial
- CompanyFirst U.S. clinical use of the B3 GEL System
- CompanyJeff Tyber appointed to the board
- Company$30 million Series A financing
- CompanyTYBR Health site; Y Combinator page; NIH SEED showcase
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
