What SafeHeal does

SafeHeal is a clinical-stage medical device company founded in 2015 in Paris, France, with a wholly-owned US subsidiary (SafeHeal Inc.) based in Tampa, Florida. The company develops Colovac, an endoluminal bypass sheath designed to protect colorectal anastomoses during the critical 10-day post-operative healing period as an alternative to temporary diverting ostomy. The system comprises two integrated components: the Colovac device (an anchor with a covered stent delimiting a vacuum chamber, a flexible cylindrical sheath covering the anastomosis, and vacuum tubes) and the Colovac SmartVac (a battery-powered vacuum system that maintains a pre-set vacuum range to anchor the device). The device is sterile, single-use, and removed endoscopically without a second surgical intervention. Colovac has been studied in over 100 patients across the US, Europe, and Asia, with greater than 80% of participating patients successfully avoiding a diverting ostomy in clinical trials.

SafeHeal targets colorectal cancer patients undergoing low anterior resection and the colorectal surgeons who treat them, with secondary stakeholders in hospital systems and payors. The device addresses anastomotic leakage, which occurs in up to 20% of anterior resection cases, by isolating the anastomosis from fecal contact during healing and reducing reliance on diverting ostomy and its associated complications (dehydration, parastomal hernia, bowel obstruction, skin issues, and quality-of-life impacts). SafeHeal is backed by MD Start (Sofinnova Partners' medtech accelerator, which created and incubated the company) and investors including Sofinnova Partners, Genesis MedTech Group, Solar Eclipse, Gideon Strategic Partners, M&L Healthcare, and Asabys Partners, with €85M+ raised cumulatively.

The company's business model is hardware sales of a single-use device, with a dedicated accessory (SmartVac) that must be used in combination. In the US, Colovac remains investigational and limited to investigational use pending FDA approval through the SAFE-3CV pivotal IDE study (up to 252 patients across up to 20 US and European sites, launched January 2026). In Europe, the device received EU MDR 2017/745 marketing approval in August 2025, enabling commercial distribution, with a dedicated VP of Health Economics & Market Access pursuing Medicare reimbursement and broader payer engagement. Distribution is via enterprise field sales targeting hospitals and colorectal surgery departments.

Name

SafeHeal

Legal name

SafeHeal SAS

Website

https://safeheal.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

SafeHeal is a clinical-stage medical device company developing Colovac, an endoluminal bypass sheath designed to protect colorectal anastomoses and potentially eliminate the need for diverting ostomy in patients undergoing colorectal resection surgery. The company targets hospitals, colorectal surgeons, and surgical oncology patients in Europe and the US.

Ownership category

akta.pro rank

Product category

Colorectal Surgical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN)

Keywords

• Colorectal anastomosis protection
• Endoluminal bypass sheath
• Ostomy alternative devices
• Surgical medical devices
• Colorectal surgery implants

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Colovac Device Sales: SafeHeal generates revenue through commercialization of its Colovac anastomosis protection device. With EU MDR marketing approval granted in August 2025, the company is preparing for commercial launch in European markets. In the US, the device remains investigational and is limited by Federal law to investigational use pending FDA approval through completion of the SAFE-3CV IDE study.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

SafeHeal develops and manufactures Colovac, a colorectal anastomosis protection device designed to reduce fecal contact at the anastomotic site following colorectal surgery, serving as an alternative to diverting ostomy. The system comprises the Colovac implant (covered stent anchor with vacuum chamber, flexible sheath, and vacuum tubes) and the Colovac SmartVac battery-powered vacuum system that maintains vacuum pressure to anchor the device during the 10-day critical healing period.

Product overview

SafeHeal is a clinical-stage medical device company developing a unified product system for colorectal surgery patients. The core portfolio consists of Colovac (an anastomosis protection device) and Colovac SmartVac (vacuum anchoring system). These two components form an integrated endoluminal bypass system where the SmartVac powers the vacuum-based anchoring mechanism of the Colovac device. The system is designed as an alternative to temporary diverting ostomy for patients undergoing colorectal resection, allowing them to avoid stoma creation while the anastomosis heals. Colovac is the primary implant device while SmartVac serves as the essential power/control component required for device function.

Differentiator

Problem solved

Functional benefit

Brands

• Colovac: Colorectal anastomosis protection device designed to reduce contact of fecal content at the anastomotic site following colorectal surgery, as an alternative to diverting ostomy.
• Colovac SmartVac

Products and services

• Colovac A sterile, single-use, disposable colorectal anastomosis protection device consisting of an anchor (covered stent with vacuum chamber), flexible cylindrical sheath covering the anastomosis, and vacuum tubes. Placed endoluminally during colorectal resection to isolate the anastomosis from fecal contact during the 10-day critical healing period, then removed endoscopically without requiring a second surgical intervention. Targeted at colorectal surgeons and hospitals performing low anterior resection procedures.
• Colovac SmartVac Battery-powered vacuum system designed to maintain accurate vacuum within a pre-set range to anchor the Colovac device in the colon. Attaches to the Colovac device via a supplied Tubing Set, continuously monitors vacuum level, and uses an onboard pump to maintain pressure within acceptable range. Required companion equipment for Colovac operation, for use by surgical teams in hospital settings.

Quantifiable outcome

• Greater than 80% of participating patients successfully avoided a diverting ostomy
• +4 more outcomes

Named customers9 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

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Patricia Sylla, MD (Principal Investigator)coreStrategic or Co-development Partner · 12 January 2026Dr. Patricia Sylla, Professor of Surgery and System Chief of Colon and Rectal Surgery at Mount Sinai Health System, serves as US Principal Investigator for the pivotal SAFE-3CV IDE study. She is a member of SafeHeal's Scientific Advisory Board.
• Prof. Jérémie Lefevre (EU Principal Investigator)coreStrategic or Co-development Partner · 12 January 2026Prof. Jérémie Lefevre of Hôpital Saint-Antoine, Sorbonne Université, Paris, serves as EU Principal Investigator for the SAFE-3CV IDE study. He successfully enrolled the first patient and has been involved in multiple Colovac clinical studies since 2018.
• MD Start (Medtech Accelerator)coreStrategic or Co-development Partner · 1 January 2015MD Start is Sofinnova Partners' in-house medtech accelerator that created and incubated SafeHeal in 2015. Anne Osdoit runs MD Start Strategy and serves as board member. The Colovac device was invented by Dr. Charam Khosrovani and developed through MD Start's accelerator model.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Colospan: Colospan develops the CG-100 intraluminal bypass device designed to protect colorectal anastomoses, representing the most direct head-to-head competitor to SafeHeal's Colovac in the colorectal anastomosis protection category.
• Applied Medical: Applied Medical manufactures a broad portfolio of laparoscopic and open surgical devices used in colorectal procedures, including access and anastomosis-adjacent instrumentation that overlaps with the procedural workflow SafeHeal targets.

Broad incumbents

• Ethicon (Johnson & Johnson): Ethicon is the market-leading surgical stapling and anastomosis franchise within J&J MedTech, supplying the dominant circular and linear stapler platforms used to create colorectal anastomoses that Colovac is designed to protect.
• Medtronic: Medtronic's Surgical Innovations business (including the Signia and Tri-Staple platforms) competes in colorectal surgery stapling and could expand into or acquire into the anastomosis protection category where SafeHeal operates.
• Boston Scientific: Boston Scientific is a broad medtech incumbent with a significant endoscopy and surgical franchise relevant to colorectal surgery, where SafeHeal's CEO previously held leadership positions and which could serve as a strategic acquirer.
• Becton, Dickinson and Company (BD): BD's Surgery and Interventional segments supply a range of colorectal and anastomosis-support products and represent a broad medtech incumbent whose portfolio overlaps the procedural setting where Colovac is used.

Emerging players

• Touchstone International (InspireMD's Collar/CGuard not relevant; Touchstone): Touchstone International has historically competed in colorectal surgery anastomosis support devices and represents an emerging or adjacent participant in the same clinical indication space as Colovac.
• Intuitive Surgical: Intuitive Surgical's da Vinci robotic platform dominates the robotic-assisted colorectal resection market where SafeHeal's Colovac would be deployed, making it a critical ecosystem participant and potential complementary technology partner.
• CooperSurgical: CooperSurgical supplies surgical and women's health devices including products used in colorectal and pelvic surgery workflows, making it an adjacent surgical device peer with potential overlap in target accounts.
• Teleflex: Teleflex offers a range of surgical instruments and access devices used in colorectal surgery and represents an emerging/specialized incumbent whose surgical portfolio partially overlaps with SafeHeal's procedural footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/safeheal
• LinkedInlinkedin.com/company/safeheal

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors7 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 SafeHeal