IVT Medical is seeking wound closure device distributors and negative pressure wound therapy partners in select territories. Represent the TopClosure® Tension Relief System and our FDA-cleared regulated NPWT line as an exclusive distributor in your market, backed by an ISO 13485 certified manufacturer and 35+ peer-reviewed publications.
Distributors do not need another me-too dressing line. They need technology that opens surgeons' doors: wound closure without skin grafts, and patented NPWT that adds oxygen and irrigation where standard systems stop. The combination of oxygen delivery with negative pressure at the wound is protected by IVT Medical's registered patents.
Work directly with the medical device manufacturer in Israel. Distribution agreements with exclusive territories, factory pricing and no intermediaries.
FDA 510(k) cleared NPWT devices, with TopClosure® FDA-listed as Class I, 510(k) exempt. Manufactured under a valid ISO 13485:2016 quality system and registered with the Israel Ministry of Health (AMAR). Full technical files, IFUs and registration support, including CSDT-based dossiers.
Registered patents protect the oxygen plus negative pressure combination (ROI-NPT) and the Vcare α® bleeding control system, backed by 35+ peer-reviewed publications, a NICE medtech innovation briefing in the UK (MIB97), and a documented clinical case library your sales team can present to surgeons on day one.
The flagship skin stretching and secure wound closure device. Enables closure of high tension wounds without grafts or flaps, in the OR, at the bedside and in the field.
Product details →
Hospital-grade regulated negative pressure wound therapy with patented oxygen-enriched irrigation (ROI-NPT). The only NPWT device in the world with a registered patent for bleeding control. FDA 510(k) cleared (K121817).
Product details →
Portable regulated negative pressure wound therapy device for professional healthcare facilities, extending advanced wound care to community, rural and low resource settings. FDA 510(k) cleared (K260426).
Product details →TopClosure® is the subject of a Medtech Innovation Briefing by NICE, the UK's National Institute for Health and Care Excellence (MIB97, 2017). A door opener your sales team can put in front of any hospital committee.
"The findings suggest that the TopClosure TRS may help secure wound closure with minimal scarring."
NICE Medtech Innovation Briefing MIB97, evidence summary
"The technology could benefit patients because it offers a less invasive skin closure method."
Specialist commentators, cited in MIB97
"All 3 commentators felt that the device had the potential to generate cost savings for the NHS."
Specialist commentator comments, MIB97
Source: NICE Medtech Innovation Briefing MIB97 (March 2017). Medtech innovation briefings provide objective information on medical technologies; they are not NICE guidance and do not constitute an endorsement by NICE.
IVT Medical works with a growing international network of distribution partners, and we review new inquiries from established medical device distributors worldwide. Select territories are currently open, with a particular focus on Asia and Latin America.
Exclusivity is granted per territory under a distribution agreement, so strong partners who move early secure their market.
Note on Europe: IVT Medical products are not currently CE marked, so we do not offer European Union distribution at this time. We believe in telling partners exactly where we stand.
The FDA does not approve devices of this class; the correct status is listing. TopClosure® is an FDA-listed Class I medical device (21 CFR 878.4320, product code MKY) and is 510(k) exempt, listed with the FDA since 2010. It is manufactured under an ISO 13485:2016 certified quality system. IVT Medical's NPWT devices, Vcare α® (K121817) and MeCare α® (K260426), are FDA 510(k) cleared.
A tension relief system is a skin stretching device that harnesses the skin's viscoelastic properties, through stress relaxation and mechanical creep, to achieve wound closure without skin grafts even under high tension. It distributes closure forces widely across the skin, away from the wound edges.
CE marking is required for sales inside the European Union. IVT Medical products are not currently CE marked, so we do not offer EU distribution at this time. In our open territories, market entry is typically based on our FDA clearances and listing, ISO 13485 certification, Israel Ministry of Health (AMAR) registration and local registration, which we actively support.
Typical registration files include the manufacturer's ISO 13485 certificate, FDA establishment registration and device listing, instructions for use, technical datasheets, sterilization data and clinical evidence. IVT Medical provides a complete technical file and walks distributors through local registration, including CSDT-based submissions where applicable.
The Common Submission Dossier Template (CSDT) is a standardized medical device registration format used across ASEAN countries and several other markets. It compiles the device description, essential principles, labeling, risk analysis and clinical evidence into one structured file. We prepare and maintain CSDT documentation for our devices.
The MeCare α® is a portable, battery-operated negative pressure wound therapy device that extends regulated NPWT beyond the hospital bed to community, rural and low resource professional care settings. Under its FDA clearance (K260426) it is indicated for use in professional healthcare facilities by trained healthcare professionals; it is not cleared for home use.
Standard NPWT applies regulated negative pressure to remove exudates and promote granulation. Instillation adds controlled fluid delivery to the wound bed. IVT Medical's ROI-NPT goes a step further, combining regulated negative pressure with irrigation and low flow oxygen delivery to help combat anaerobic infection. This combination of oxygen and negative pressure at the wound is protected by IVT Medical's registered patents.
Tell us about your company, your market and the product lines that interest you. Our team reviews every distribution inquiry personally.