Company:Fractyl Health

From HandWiki
Fractyl Health, Inc.
FormerlyFractyl Laboratories
TypePublic
NASDAQ: GUTS
Industry
Founded2010; 16 years ago (2010)
Founders
  • Jay Caplan
  • Harith Rajagopalan
Headquarters
Burlington, Massachusetts
Key people
Number of employees
88[2] (2024)
Websitefractyl.com

Fractyl Health is a Burlington, Massachusetts-based[3] healthcare company focused on metabolic diseases like obesity and type 2 diabetes.[4] The company developed Revita, an outpatient endoscopic procedure to modify duodenal dysfunction, and Rejuva, a gene therapy platform in preclinical development to enable the pancreas to produce glucagon-like peptide-1 (GLP-1).

History

Harith Rajagopalan, MD, PhD, and Jay Caplan established Fractyl Health, initially named Fractyl Laboratories,[5] in 2010.[6] The company's Revita device gained CE marking in April 2016[7] and became commercially available in the UK in January 2020.[8] In April 2021, the US Food and Drug Administration (FDA) gave Revita breakthrough device designation to treat type 2 diabetes.[9] The company changed its name to Fractyl Health in June 2021.[10]

In April 2022, the FDA approved an investigational device exemption trial for Revita.[11] It became available commercially in Germany in early 2023.[12] The FDA issued additional breakthrough device designation to Revita in July 2024 for weight maintenance in certain people with type 2 diabetes or obesity.[13][14]

Fractyl had an initial public offering on the Nasdaq in February 2024.[15] As of February 2025,[16] the company's REMAIN-1 study is evaluating Revita for patients with obesity to support weight maintenance after use of a GLP-1 drug.[17] In January 2025, Fractyl announced it would focus research for Revita on obesity and people on GLP-1s,[18] citing rising demand driven by the popularity of GLP-1s.[19] The company also laid off some employees focused on type 2 diabetes treatment.[20]

Products

Fractyl's therapies focus on the root causes of metabolic diseases like obesity.[4]

Revita

Revita is an outpatient endoscopic procedure that resurfaces the mucosal lining of the duodenum using ablation with water and heat.[13][21] The duodenal lining can thicken with chronic high-fat and high-sugar diets;[22] this can damage signaling mechanisms in the gastrointestinal tract[13] and lead to metabolic disease.[23][24] After resurfacing, a healthy mucosal layer can regrow over time, potentially improving blood sugar regulation[5] and insulin sensitivity.[22]

Rejuva

Rejuva is an adeno-associated virus (AAV)-based gene therapy platform to enable the pancreas to produce GLP-1 on an ongoing basis as a treatment for obesity and type 2 diabetes.[25] The therapy targets dysfunctional beta islet cells in the pancreas.[26] Delivery is done with a needle catheter to deliver viral vectors into the pancreas.[26]

In January 2025, Rejuva completed Clinical Trial Application-enabling preclinical in vivo studies,[27] beginning its first-in-human studies in the first half of 2025.[28]

References

  1. ↑ LaHucik, Kyle (29 January 2024). "Fractyl has the GUTS: Obesity and diabetes biotech charts $99M IPO" (in en). Endpoints News. https://endpts.com/obesity-biotech-fractyl-health-eyes-99m-ipo-after-cg-and-arrivent-success/. 
  2. ↑ Fonseca, Camilo (18 January 2024). "Lexington-based Fractyl Health, focused on non-drug treatments for diabetes and obesity, filing for IPO". The Lexington Observer. https://lexobserver.org/2024/01/18/diabetes-and-obesi-treatment/. 
  3. ↑ "Form 8-K: Fractyl Health, Inc.". U.S. Securities and Exchange Commission. 24 June 2024. https://www.sec.gov/Archives/edgar/data/1572616/000095017024076424/guts-20240624.htm. 
  4. ↑ 4.0 4.1 "Fractyl Health valued at $654.6 mln in tepid debut". Reuters. 2 February 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/fractyl-health-valued-6546-mln-tepid-debut-2024-02-02/. 
  5. ↑ 5.0 5.1 Hale, Conor (16 June 2021). "Fractyl nets $100M to complete development of its intestine-resurfacing device for Type 2 diabetes" (in en). Fierce Biotech. https://www.fiercebiotech.com/medtech/fractyl-nets-100m-to-complete-development-its-intestine-washing-device-for-type-2-diabetes. 
  6. ↑ Green, Hannah (2 February 2024). "Lexington biotech raises $110M in first Mass. IPO of 2024". Boston Business Journal. https://www.bizjournals.com/boston/news/2024/01/29/lexington-based-fractyl-health-ipo.html. 
  7. ↑ "Fractyl Completes $44M Series D Financing". FinSMEs. 30 November 2017. https://www.finsmes.com/2017/11/fractyl-completes-44m-series-d-financing.html. 
  8. ↑ Kent, Chloe (28 January 2020). "Revita type II diabetes treatment launches in London". Medical Device Network. https://www.medicaldevice-network.com/news/revita-diabetes-treatment/. 
  9. ↑ Whooley, Sean (27 April 2021). "FDA grants breakthrough nod for Fractyl's type 2 diabetes treatment". Drug Delivery Business. https://www.drugdeliverybusiness.com/fda-grants-breakthrough-nod-for-fractyls-type-2-diabetes-treatment/. 
  10. ↑ DeFeudis, Nicole (16 June 2021). "After a decade in the type 2 diabetes game, Fractyl Laboratories recharges with a fresh $100M and a new name" (in en). Endpoints News. https://endpts.com/after-a-decade-in-the-type-2-diabetes-game-fractyl-laboratories-recharges-with-a-fresh-100m-and-a-new-name/. 
  11. ↑ Whooley, Sean (4 April 2022). "FDA approves IDE trial for Fractyl Health's diabetes reversal tech in type 2 diabetes patients". Drug Delivery Business. https://www.drugdeliverybusiness.com/fda-approves-ide-trial-for-fractyl-healths-diabetes-reversal-tech-in-type-2-diabetes-patients/. 
  12. ↑ "Fractyl's Revita DMR System commercially available in Germany" (in en). Bariatric News. 8 February 2023. https://www.bariatricnews.net/post/fractyl-s-revita-dmr-system-made-commercially-available-in-germany. 
  13. ↑ 13.0 13.1 13.2 Barrie, Robert (8 August 2024). "Fractyl Health touts positive year-long weight loss results for Revita device". Clinical Trials Arena. https://www.clinicaltrialsarena.com/news/fractyl-health-touts-positive-year-long-weight-loss-results-for-revita-device-2/?cf-view. 
  14. ↑ Gallagher, Ashley (1 August 2024). "FDA Grants Breakthrough Device Designation for System Maintaining Weight Loss After GLP-1" (in en). Pharmacy Times. https://www.pharmacytimes.com/view/fda-grants-breakthrough-device-designation-for-system-maintaining-weight-loss-after-glp-1. 
  15. ↑ "Fractyl Health raises $110 mln in US IPO". Reuters. 2 February 2024. https://www.reuters.com/markets/deals/fractyl-health-prices-us-ipo-below-range-raise-110-mln-2024-02-02/. 
  16. ↑ Beard, David (9 February 2025). "WVU Medicine leads trial of procedure to maintain weight loss without GLP-1 drugs". The Dominion Post. https://www.dominionpost.com/2025/02/09/wvu-medicine-leads-trial-of-procedure-to-maintain-weight-loss-without-glp-1-drugs/. 
  17. ↑ Philpott, Jenna (2 April 2024). "Fractyl Health receives IDE approval for Revita trial". Clinical Trials Arena. https://www.clinicaltrialsarena.com/news/fractyl-health-receives-ide-approval-for-revita-trial/. 
  18. ↑ Hale, Conor (31 January 2025). "Fractyl Health pivots Type 2 diabetes device therapy toward obesity and GLP-1s, lays off 17% of staff" (in en). Fierce Biotech. https://www.fiercebiotech.com/medtech/fractyl-health-pivots-type-2-diabetes-device-therapy-toward-obesity-and-glp-1s-lays-17. 
  19. ↑ Baxter, Amy (10 February 2025). "Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments". PharmaVoice. https://www.pharmavoice.com/news/biotech-long-term-metabolic-glp1-fractyl-health/739606/. 
  20. ↑ Green, Hannah (31 January 2025). "Burlington biotech slims down 17% of workforce, focuses on weight maintenance treatment". Boston Business Journal. https://www.bizjournals.com/boston/news/2025/01/31/fractyl-layoffs-weight-maintenance-diabetes.html. 
  21. ↑ Lawrence, Stacy (14 October 2015). "FierceMedicalDevices' 2015 Fierce 15" (in en). Fierce Biotech. https://www.fiercebiotech.com/special-report/fiercemedicaldevices-2015-fierce-15#32dd9729-97d8-48bc-8c5a-f297844cd6e8. 
  22. ↑ 22.0 22.1 Hale, Conor (23 May 2022). "Fractyl's Type 2 diabetes device therapy spurs pancreas function" (in en). Fierce Biotech. https://www.fiercebiotech.com/medtech/fractyl-shows-its-intestine-resurfacing-device-type-2-diabetes-improves-insulin-resistance. 
  23. ↑ Patchen, Tyler (1 April 2024). "Fractyl Secures FDA Approval for Weight Maintenance Study After Discontinuation of GLP-1s". BioSpace. https://www.biospace.com/fractyl-secures-fda-approval-for-weight-maintenance-study-after-discontinuation-of-glp-1s-study. 
  24. ↑ Godkin, David (17 August 2023). "A little intestinal fortitude sees Fractyl on track to reverse the root causes of T2D" (in en). BioWorld. https://www.bioworld.com/articles/700045-a-little-intestinal-fortitude-sees-fractyl-on-track-to-reverse-the-root-causes-of-t2d?v=preview. 
  25. ↑ Grinstein, Jonathan D. (23 June 2024). "Fractyl Health's GLP-1 Gene Therapy Outperforms Semaglutide in Mice". Inside Precision Medicine. https://www.insideprecisionmedicine.com/topics/translational-research/fractyl-healths-glp-1-gene-therapy-outperforms-semaglutide-in-mice/. 
  26. ↑ 26.0 26.1 Floersh, Helen (24 June 2024). "Fractyl's GLP-1 gene therapy makes weight loss last in mice" (in en). Fierce Biotech. https://www.fiercebiotech.com/research/when-wegovy-stops-weight-gain-starts-could-glp-1-gene-therapy-change. 
  27. ↑ Ford, Omar (31 January 2025). "Fractyl to Lay Off 17% of Workforce" (in en). Medical Device and Diagnostic Industry. https://www.mddionline.com/diabetes/fractyl-to-lay-off-17-of-workforce. 
  28. ↑ Samorodnitsky, Dan (31 January 2025). "Fractyl Goes All In on GLP-1 Off-Ramp Drug, Lays of 17% of Workforce". BioSpace. https://www.biospace.com/business/fractyl-goes-all-in-on-glp-1-off-ramp-drug-lays-of-17-of-workforce. 



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