Replacing a Centuries-Old Gynecological Instrument

MedTech at swissnex 02|The Swiss startup Aspivix is scouting the United States for developing its new surgical device, with the support of swissnex Boston.

Aspivix instrument (right) aims to replace the cervical tenaculum (left). / DR

Aspivix is developing a new surgical instrument for gynecologists. Its patented tool aims to make certain procedures more comfortable and safer by avoiding the use of cervical forceps. Aspivix CEO Mathieu Horras traveled to the United States to meet medical doctors, FDA experts, and business partners. With the help of swissnex Boston, he made the most of his three weeks in the US, building the foundation of an American strategy for his company.

swissnex Boston: Aspivix is not a spin-off from a university lab or a larger company, which is rather unusual for a Swiss MedTech startup. Can you tell us how you started?

Mathieu Horras: It all began with Geneva gynecologist and co-founder David Finci, who wanted a replacement solution for a tool named cervical tenaculum. It is a sharp, piercing forceps used to hold the cervix and access the uterus, which frequently causes pain and bleeding. David wanted a gentler and less traumatic instrument. He discussed his idea with his brother Julien, who is an engineer from the Swiss Institute of Technology in Lausanne. I knew Julien from our previous work together at a large medical company. We were not working on the same projects but sometimes went for a run together at lunch. This is when he told me about their idea. They lacked expertise in finance and marketing, my specialty, so Julien asked me if I was interested in joining.

“We are definitely older than the typical startup founders!”

And so you launched a startup after a long experience in a well-established company.

Yes. We are definitely older than the typical startup founders! Our past experience in a larger company gave us an edge. Medtech is a highly regulated sector, and we had already learned over the years how to tackle these complex problems. On the other hand, we were not really aware of the Swiss startup scene, we had to learn the system on the way.

Julien Finci (left) and Mathieu Horras (right), co-founders of Aspivix. © Zuzanna Adamczewska-Bolle

Why is the US market interesting for you?

The United States alone represents half of the global MedTech market, it is huge. But we have more specific reasons to be interested in doing business here. We expect gynecologists to use our surgical instrument mainly for placing IUDs. The United States IUD market is still growing, while the European one is fragmented and stable. At the beginning of the 2000s, only 1 or 2% of American women of childbearing age had an IUD, compared to a global average of 14%. This gap was mostly due to the Dalkon Shield, an awfully bad product commercialized in the US in the ’80s and linked to several cases of pelvic inflammatory disease (PID) and subsequent infertility.

The situation started to change some years ago when better and safer products were launched. But their high price prevented the market from significantly growing, and the FDA was extremely careful in approving new products, which did not help either. Recently, more options have become available, prices have dropped and Obama’s Affordable Care Act promotes provider reimbursement of birth control. Now, around 10% of American women of childbearing age have an IUD, and the market still has room to grow.

“The market has room to grow, prices have dropped and Obama’s Affordable Care Act promotes provider reimbursement of birth control.”

What kind of problems does one have to tackle to prepare for entry into the US market?

First, there are all the reimbursement questions. Do we have to register our tool with the insurance providers? Who is going to pay, the providers, the physician, the patient? The answers might be obvious for someone working in the United States, but certainly not for us. Then, you have to find consultants to help you get FDA approval. This is a highly regulated and quite a complex procedure. Finally, I also wanted feedback from American medical doctors. I had to verify with them that our instrument was compatible with their procedures. My assumption was that there is no difference between American procedures and their European counterparts, which would make our device as relevant here in terms of added values for both doctors and their patients. But this is definitely something you want to check beforehand!

“Who is going to pay, the providers, the physician, the patient? The answers might be obvious for someone working in the United States, but certainly not for us.”

How did swissnex help you reach your goal during this business trip?

People at swissnex were really good at using their network, especially to connect us with prominent medical doctors from the best American hospitals. These are not the kind of people you easily get in touch with. Not only could I get valuable feedback, but I also met physicians who could potentially join our advisory board or who could collaborate on future clinical trials. They also put me in contact with two FDA consultants. I think I could have done this part myself, but it would have been quite time-consuming. Finally, I had an office space at swissnex Boston where to meet potential partners. All this support was extremely valuable.

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