ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a leading platform neurosurgery company, today announced a strategic agreement with PTC Therapeutics, Inc. (“PTC”). The scope of the agreement includes hardware, software, clinical case and market development services for gene therapy cases in the United States and Europe to support PTC’s potential commercialization in gene therapy globally upon regulatory approval. In addition to the announcement of this agreement, ClearPoint Neuro today announces the following 2020 Outlook for the company’s performance:
- 2020 Revenue expected between $14.0-$15.0M, representing growth of approximately 25-35%;
- 2020 Revenue from Biologics & Drug Delivery Products and Partnerships of approximately $5.0M;
- 2020 Case Volume covered by Clinical Specialists between 900 and 950 cases, representing growth of approximately 15%; and
- 2020 Cash Burn from Operations (not including interest payments) from $3.0M-$3.5M
“We have put a tremendous amount of thought and effort into redefining our Company over the past two years,” commented Joe Burnett, President and CEO of ClearPoint Neuro, Inc. “This has included the vision, the team, the partnerships, and even the name of our company which officially changed this week to ClearPoint Neuro from MRI Interventions. We are thrilled by the evolution our Company has already undergone and believe we have only scratched the surface of the significant potential ahead.”
“We have evolved to become two companies in one,” continued Burnett. “On one side, we are a platform medical device company, consistently delivering double digit growth, and continuing to expand our installed base of neurosurgery centers in the U.S. Every year more surgeons and more patients gain access to the ClearPoint system and compatible disposable devices. On the other side of the business, we are a gene therapy and biologics enabling company, providing navigation, drug delivery, and case support to more than 20 companies in this exciting and growing space. Here we currently support pre-clinical and clinical efforts, but we believe that we are on the precipice of potentially explosive growth as these therapies progress through the regulatory process toward commercial launch. We feel that our company represents both scale and purpose through a unique combination of predictable device growth and a potential biologics opportunity, all supported under a common team dedicated to treating the most debilitating neurological disorders.
ClearPoint Neuro’s revenue outlook for 2020 includes an expectation that approximately 33% of total revenue will be derived from biologics and drug delivery products and services, up from approximately 20% in 2019, and reflecting the growth of this part of the business.
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“When planning for the development and potential commercialization of gene therapy globally, safety, consistency and predictability are crucial constructs that all must be included,” commented Marcio Souza, Chief Operating Officer of PTC Therapeutics and ClearPoint Neuro Board Member. “Our agreement with ClearPoint Neuro is designed to provide standardization across all of our centers of excellence as we can maintain consistency in navigation, delivery and clinical support. The more variables we can control, the more successful we believe the outcomes for patients will be.”
“As part of our Company’s duality in devices and biologics, we are thrilled to deepen our partnership with PTC,” commented Jacqueline Keller, Vice President and Program Manager at ClearPoint Neuro for the PTC Partnership. “This new agreement with PTC highlights a ‘turn-key’ solution for our gene therapy partners, whereby our commercial organization, with deep relationships in the neurosurgery community, can take on the burden of sales and clinical activities in the surgical suite, and allow our partners who are commonly small-molecule focused companies to continue to prioritize their efforts with neurologists, patients and reimbursement administrators. With the capacity to support thousands of cases each year, our team plans to provide this service across multiple companies and indications in neuro.”
Source: Biospace