RNS!!!!!22 Mar 2023 07:58
Great update!
Funded until mid 2024!
On target for commercialisation for both this year!
'Strong progress on rollout strategy
In line with its strategic plan, the Company is working with three leading US transplant centres in the Tutivia ™ commercial launch and is supporting them with the adoption and integration of the test into the current clinical pathway, to encourage consistent and recurring utilisation. This is providing a valuable foundation for Verici Dx to make Tutivia™ as simple as possible for clinicians to use and interpret.
Following the successful progression of the Company's laboratory registration status to Compliance Certification by the Centers for Medicare & Medicaid ('CMS'), allowing its commercial operation for samples received from patients in 45 US states, Verici Dx is ready to build on the initial rollout activity over the course of 2023. Medicare and Medicaid account nationally for about 65% of all transplant patients and the Company is focused the initial rollout of the test where the proportion of Medicare patients is higher than the national average. To further drive adoption the Company has addressed the pricing and coverage determinations under Medicare. This is administered by the MolDx region of Palmetto given the Company's laboratory is based in Tennesse. The Company submitted its pricing proposal in Q1 2023 and expects to get the MolDx pricing recommendation by the end of Q2 2023. The Company is currently preparing its submission for Medicare insurance reimbursement coverage, under the Local Coverage Determination (LCD) offered in Palmetto and a coverage determination is expected later this year. Registration for Medicaid has been approved in three states and submitted in a further 11 states as well as with BlueCross Blue Shield of Tennessee, the largest health benefit plan company in the state.
Prudent cash management and execution
As of 31 December 2022, the Company had a cash balance of $9.81m. The Company has taken headcount reduction and clinical trial cost containment steps in recent months and, as a result, has extended the current cash runway to last until mid-2024. The Company is focused on early revenue generation during the first half of this year and will seek to extend and broaden its revenue streams from additional centres in the second half of 2023.
The Company expects to report its preliminary results for the year ended 31 December 2022 by the end of April 2023.
Sara Barrington, CEO of Verici Dx, said:
"We have continued to make significant progress in executing our strategy, resulting in the full commercial launch of Tutivia ™ in January, with Clarava's™ initial launch expected before the end of this year.
"We achieved our internal target of attracting three key, leading US transplant sites as early adopters for Tutivia ™, a critical step that is enabling us to demonstrate the adoption and integration process for clinicians.