Clinica's MedTech Ventures: Reapplix

Clinica’s MedTech Ventures: Reapplix
Specialty area(s): Wound care
Based in: Birkerød, Denmark
Founded in: 2008
No. of employees: 6
Total investment received to date: £6m ($9.6m)
Investors: Novo Seeds, SEED Capital and Vækstfonden (The Danish Growth Fund)

As the incidence of diabetes rises, so does the number of patients suffering from diabetic foot ulcers. In the US around 250,000 hard-to-heal ulcers are treated each year, costing the healthcare service around $11bn.

But treatment with current methods is not always successful, with around 30% of these ulcers not healing, estimates Graeme Brookes, the new CEO of Danish wound care specialist Reapplix. The company has developed a product, called LeucoPatch, which is produced from the patient’s own blood in around 20 minutes and could improve wound healing.

A small blood sample, around 18ml, is placed in the firm’s single-use device, a small vacuum container which is then put in a centrifuge. “It doesn’t have to be a special centrifuge. It just has to run at a specific cycle; time and speed,” says Mr Brookes. “The device design, which is patent protected, generates the patch under certain centrifugation parameters.”

After centrifugation, what emerges from the vacuum device is a three-layered patch – which is also covered by Reapplix’s IP. “The top layer is fibrin, which gives it structure and helps with moisture retention in the wound; the middle layer is made up of platelets, which release a high amount of growth factors; and the bottom, which is the wound contact layer, that contains leucocytes. And they are very important for fighting infection, and assisting and orchestrating the healing process.”

This patch is then applied directly to the surface of the patient’s wound. Mr Brookes concludes: “So basically we are putting back on the wound all the body’s own active components to boost wound healing. There are no additives involved at all; it’s a fully autologous product, just from the patient’s blood.”

And producing the patch should fit in well with current hospital practices, according to the CEO. “Typically in a wound care center, the patient comes in and the doctor will take their blood straightaway and set the centrifuge going. Then the nurse would remove the [existing] dressings, clean the wound, and take some patient history – and by the time they’ve done that, the patch is ready.”

LeucoPatch is already CE marked and Reapplix is currently in the process of carrying out a randomized, controlled trial in diabetic foot ulcers. The company expects to report interim results in 2015 and complete the study in 2016.

“In parallel with the trial, we’ll be undertaking some commercial activity,” Mr Brookes says. “We’re looking at diabetic foot ulcers initially, but LeucoPatch is actually effective in a number of other indications. So we could use these key [clinical] sites to do some initial evaluations for other indications, and also to learn about product usability, and to find out about the reimbursement environment in different European countries. So it’s that type of commercialization activity that I’ll be handling.”

US approval

Reapplix is also already making headway in the US. “We already have IDE approval [from the FDA] and if we wanted to undertake our trial in the US we could, or we could file for US approval based on EU data. And the other important element in the US is reimbursement, and we’ve already been through a process with CMS and obtained what is called coverage for evidence development, for the trial. Which means if we were to set up trial centers in the US, the product would be reimbursed as it stands now.”

The company is currently deciding “whether we widen the current trial or how we build a US strategy. I think the way we’ve used our interaction with the FDA and CMS so far is to validate that our trial is acceptable from their perspective, and to create some connectivity there.”

The CEO says the positive decision from CMS has “given us the confidence that CMS will look at the trial data that we gather in Europe.” However, he added, “our strategy for reimbursement in the US is still something that we’re working through. It’s a work in progress.”

Reapplix hopes to file for FDA approval in the first half of 2015.

Mr Brookes estimates that potential revenue from LeucoPatch in diabetes foot ulcer could be “into the hundreds of millions of dollars. Beyond that, we’ve got the opportunity of other indications like venous leg ulcers and other hard-to-heal wounds.”

As for Reapplix’s competition, there are several potential rivals that the firm will be going up against. This ranges from big companies in the negative pressure wound therapy (NPWT) space, including Kinetic Concepts and Smith & Nephew, to those with active wound care products such Organogenesis (Apligraf and Dermagraft), and S&N, with Regranex. “It’s those active wound care products that we’ll be competing with,” Mr Brookes says.

In addition, there are players developing tissue- and cell-based products including UK firm Tissue Regenix, which launched its flagship DermaPure product in the US this year; and S&N again, through its purchase of Healthpoint Biotherapeutics in 2012.

But LeucoPatch has an advantage over all of these, the CEO adds. “Our differentiator to those products is we can provide leucocytes. They have a dual function: they orchestrate the healing process; and they fight infection. That’s a unique element of our product.”

In another difference, LeucoPatch is removed after a week (it can be replaced by another fresh patch if required) rather than integrating into the wound care sites like some other products. “Those other devices are skin substitutes, if you like. We’re not trying to be a skin substitute, what we’re trying to do is be a vehicle for providing growth factors and leucocytes back into a wound site.”

Finally, the high cost of some current wound care products can be a drawback, Mr Brookes continues. “These products are cultured or freeze dried, or some are actually delivered frozen. They’re expensive to produce, and they also require handling in use. Whereas with our product, you literally take a blood sample and spin it for 20 minutes. So you’re able to produce the patch on demand, in a low cost manner, in a workflow that already fits in with the clinician’s existing work pattern.”

This means “we’re going to be able to position it at much lower cost levels than some of those other products we talked about.” Which could give Reapplix a big advantage over some of the other wound care players, especially in this cost-conscious age.

Graeme Brookes, CEO. [phone]; [email protected]

Reapplix ApS, Blokken 45, 3460 Birkerød, Denmark

http://leucopatch.com/index