Company: GT Medical Technologies Nomination Submitted by: Brodeur Partners Company Description: Driven to overcome the limitations of current treatments for brain tumors and raise the standard of care, a team of brain tumor specialists joined forces and formed GT Medical Technologies with the purpose of improving the lives of patients with brain tumors. Its GammaTile Therapy is now available in top brain tumor centers across the United States. Nomination Category: Company / Organization Categories Nomination Sub Category: Company of the Year - Health Products & Services - Small
Nomination Title: GT Medical Technologies
- Which will you submit for your nomination in this category, a video of up to five (5) minutes in length about the achievements of the nominated organization since January 1 2020, OR written answers to the questions for this category? (Choose one):
Written answers to the questions
- If you are submitting a video of up to five (5) minutes in length, provide the URL of the nominated video here, OR attach it to your entry via the "Add Attachments, Videos, or Links to This Entry" link above, through which you may also upload a copy of your video.
- If you are providing written answers for your submission, you must provide an answer to this first question: Briefly describe the nominated organization: its history and past performance (up to 200 words):
Total 200 words used.
In 2017, a group of brain tumor specialists joined to form GT Medical Technologies with the simple purpose of improving the lives of patients with brain tumors. In January 2019, the company introduced its breakthrough medical device GammaTile® Therapy, a safe and effective Surgically Targeted Radiation Therapy (STaRT) for operable brain tumors.
Fundamentally different from external beam radiation (EBRT), GammaTile Therapy is a “one-and-done” treatment, implanted at the time of brain tumor removal surgery using collagen-based tiles embedded with optimally spaced radiation sources. Treatment starts immediately and continues as patients go about their daily lives. With traditional EBRT, patients typically must wait for the surgical wounds to heal before starting treatment. From there, it often requires as many as 30 treatments for many consecutive weeks. Patients and families are faced with the daily burden of time and travel to the medical center. In addition to sparing patients and families the time and energy that traditional EBRT treatments would require, GammaTile Therapy helps minimize patients’ potential exposure to COVID-19 by eliminating the need for ongoing radiation appointments. Clinical data demonstrates that immediate radiation improves local tumor control and can extend survival in patients who are treated with surgery plus GammaTile Therapy.
- You have the option to answer this final question: Reference any attachments of supporting materials throughout this nomination and how they provide evidence of the claims you have made in this nomination (up to 250 words):
Total 141 words used.
- If you are providing written answers for your submission, you must provide an answer to this second question: Outline the organization's achievements since the beginning of 2020 that you wish to bring to the judges' attention (up to 250 words):
Total 250 words used.
- In January 2020, the company received expanded FDA 510(k) regulatory clearance to include patients with newly-diagnosed malignant brain tumors, including gliomas and brain metastases.
- In August, 2020, the company announced data demonstrating positive local control and safety outcomes with GammaTile for large brain metastases. The study, conducted at the Barrow Neurological Institute in Phoenix, AZ, found that in patients with recurrent brain metastases who underwent surgery followed by GammaTile, there was a statistically significant improvement in time-to-local disease progression compared to the same patients’ prior rounds of treatment.
- In November, 2020, the first patient was enrolled into the company’s registry trial of GammaTile, a study to evaluate the safety and effectiveness of GammaTile in a real-world setting in up to 50 brain tumor centers across the U.S.
- In November 2020, The University of Texas MD Anderson Cancer Center began enrollment for a multicenter, randomized phase III trial of GammaTile. The study is comparing outcomes of 180 patients with newly diagnosed, large brain tumors who received the standard of care treatment, resection surgery and stereotactic radiotherapy, to those treated with resection surgery and GammaTile.
- In November 2020, the company raised $16 million in a Series B financing led by MVM Partners with participation from existing investors MedTech Venture Partners and BlueStone Venture Partners.
- In May 2021, Novocure entered into a clinical trial collaboration agreement with the company to develop Tumor Treating Fields together with GammaTile for treatment of recurrent glioblastoma. Novocure’s TTFields are electric fields that disrupt cancer cell division.
- If you are providing written answers for your submission, you must provide an answer to this third question: Explain why the achievements you have highlighted are unique or significant. If possible compare the achievements to the performance of other players in your industry and/or to the organization's past performance (up to 250 words):
Total 249 words used.
There hasn’t been an improvement to the standard treatment care protocol for patients with brain tumors in over ten years. Even with full market release concurring with the start of a global pandemic in March of 2020, resulting in significant challenges relating to hospital access, GammaTile is now in over 50 top brain tumor centers across the United States.
Currently, there’s no other device on the market that can achieve what GammaTile Therapy does for its patients—it’s the first brain tumor device of its kind. Some might consider long-standing brain tumor treatments that serve as the standard of care in oncology as GammaTile Therapy's competitors. GT Medical Technologies believes it's important to individualize treatment and provide all options to the patient. Progress in cancer treatments is not about competition, it’s about expanding the array of therapies, so patients and their providers can optimize options. GammaTile Therapy was developed to meet an unmet clinical need, providing a safe and effective option for patients who had/have none.
The extended FDA clearance the company received was a significant step because patients with newly diagnosed malignant brain tumors became eligible for GammaTile, as opposed to just patients with recurrent brain tumors.
The clinical trials focused on GammaTile by leading healthcare institutions demonstrate the importance of the treatment and the willingness of the healthcare community to embrace it. The clinical data noted demonstrates that immediate radiation improves local tumor control and can extend survival in patients who are treated with surgery plus GammaTile Therapy.
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