SUMMARY: Thermatome is developing disruptive medical devices that utilize heat to destroy residual cancer cells in the tissue surrounding a surgical cavity. The first application is for breast cancer lumpectomy surgery, where use of Thermatome devices will provide patients with an alternative to several weeks of daily radiation treatment post-surgery, avoiding radiation induced side effects and reducing per patient costs by as much as $30K. Second application can be applied to in-office therapy eliminating the need for lumpectomy surgery and radiation while reducing costs by as much as $60k.
Thermatome plans to submit for FDA de novo clearance as a Class II medical device, with general intended use of soft tissue ablation (cell destruction), in early 2021. FDA de novo clearance will be followed by limited product launch and clinical trials to support FDA 510(k) clearance with specific intended use to treat lumpectomy margins. Full market launch is expected in 2022. Early exit opportunities upon execution of additional IP in 2021.
PROBLEM: Current standard to treat early stage breast cancer is Breast-Conserving Therapy (BCT), consisting of lumpectomy surgery to remove the tumor, leaving the breast intact, followed by radiation to treat residual cancer. The radiation therapy requires daily treatments for up to six weeks following surgery, with potential adverse side effects and significant time away from family and work, costing payers up to $40K per patient.
SOLUTION: Thermatome’s alternative to radiation is a balloon-catheter and control unit system (US patent # 8,486,127). A one-time, 20-minute procedure performed by surgeons immediately following lumpectomy, a balloon is placed in the lumpectomy cavity and filled with saline fluid. Fluid is heated to uniformly raise tissue temperature around the balloon, necrotizing tissue and destroying residual cancer cells. A secondary solution (US 2019 / 0021778 A1) to treat the tumor by image guided removal immediately followed by 20-minute thermal therapy is in-process.
PROVEN FEASIBILITY: Thermatome has developed prototype systems and demonstrated feasibility with published animal tests and human case studies.
MARKET: 295K new breast cancer diagnoses annually in US, 180K eligible for BCT. Total annual diagnoses expected to be 440K by 2030, with much of growth in early stage cancers (BCT candidates). Annual addressable market for Thermatome is $450M US, $2B global. Initial market: 10K patients annually who had previous BCT, and have local cancer recurrence (patients can’t be re-treated with radiation in same breast), and 20K annual BCT eligible patients, who currently choose mastectomy to avoid cost, travel and/or side effects of radiation.
COMPETITION: Whole breast radiation, current standard for BCT, requires up to 6 weeks of daily treatment with potential short- and long-term side effects. Brachytherapy localizes radiation at the lumpectomy site, with twice daily treatments for up to 10 days. Thermatome is lower cost, more convenient, with fewer side effects and equally as effective treating the surgical margins. Other ablative devices, such as cryoablation and radiofrequency (RF), can be effective for local tumor treatment. But they are not likely to be as effective as Thermatome’s flexible, fluid-filled and heated balloon for treating a uniform zone of tissue around an irregular shaped lumpectomy cavity.
TEAM: Dr. Kambiz Dowlatshahi, Founder, CMO. World renowned breast surgeon. Developed several minimally invasive techniques for cancer surgery. Christopher Valadez, Co-Founder, COO, Product Development Director. Experience bringing advanced surgical techniques from lab to clinical settings. Thermatome partners with industry experts in product development, regulatory, clinical trials, reimbursement and manufacturing.
FUNDING/TIMELINE: Thermatome is currently raising $2.5 million, with a first tranche of $200k to execute additional IP. Second tranche of $750k for: 1) device development, build and testing, 2) FDA pre-submission, 3) operations, and an additional $1.5million in late 2021 for: 1) full-scale product development to FDA standards, 2) animal testing, 3) FDA de novo submission/clearance, 4) clinical trial planning, 5) operations. Development and testing to date has been completed with $225K founder funds, donations, grants. Additional funding: $6-7 Million for clinical trials and commercialization. Upon successful clinical trials, significant market penetration could begin as early as Q2 2022, with up to 10% market penetration by 2023.
EXIT: With greater than 80% gross margins for the disposable balloon-catheter, Thermatome will be an attractive acquisition target for strategic medical device consolidators. Strategic discussions with potential acquirers will be initiated upon generation of test data required for FDA de novo submission. Potential early exit opportunities upon execution of additional IP in late 2021.