During its CMD yesterday, Biovica updated the market on its planned go-to-market strategy, which is now focused on establishing a CLIA lab. In our view, the important factor is to establish awareness and convince KOLs, and Biovica is currently building its sales organization to do this. This model will provide a direct relationship with all the relevant stakeholders, (patients, physicians & payers), which we believe could prove beneficial to optimize its offering to facilitate uptake. We believe standardized reimbursement coverage will be important for broader use, but the company will enter the market with a combination of hospital contracting, insurance and co-pay initially.
Multiple pathways to position DiviTum
Biovica has developed a broad base of clinical evidence, and this creates multiple potential pathways to position DiviTum in the market. One such pathway is to stratify patients to design treatments, on the back of the prognostics value it has shown at baseline measurement. Another area is to confirm treatment response or alter non-responding treatments through continuous monitoring, on the basis of the different TKa patterns identified from continuous monitoring. Supported by the budget impact model, Biovica will initially position DivTum towards cost savings, but as usage increases it would also like to establish a benefit in improving clincal outcomes.
510(k) resubmitted, clearance decision within months
Looking forward, the key milestone is achieving the long-awaited 510(k) clearance, after which Biovica will launch the product in the US. The updated application was submitted on 28 April and under the regular review times a potential clearance decision should be given within 1-2 months from that date. We believe the uncertainty surrounding the response time from the FDA continues to ...
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