- The company's SIRA® RFA Electrosurgical Device
designed specifically for patients undergoing breast-conserving
surgery (BCS)
- Breast cancer is the second most common cancer worldwide
with over 2.3M new cases each
year1
CHICAGO, July 16,
2024 /PRNewswire/ -- Innoblative Designs, Inc.
(Innoblative), a private medical device company addressing clinical
unmet needs for patients with breast cancer, announced today that
it has initiated its first-in-human clinical experience,
successfully treating a 64-year-old patient with stage II luminal A
breast cancer. The initial lumpectomy case was performed by Dr.
Cem Yilmaz, Breast Surgeon and
Founding Director of the Istanbul Oncology Hospital in Istanbul, Turkey.
"I am thrilled to perform the first clinical case with the SIRA
device and am impressed by its performance. It was extremely easy
to use, and I was able to completely ablate the cavity
post-lumpectomy without complications," stated Dr. Yilmaz. "This is
incredibly exciting as it allowed me to easily address residual
cancer in the surrounding tissue at the time of the initial
procedure, eliminating the need for my patient to undergo
subsequent radiation therapy or reoperations. I believe this will
be a game-changer with the potential to make breast conservation
surgery a more palatable option for patients."
Breast cancer is a significant global health concern with
documented impact in all countries.1 Once diagnosed,
patients are faced with difficult decisions regarding available
treatment options. Breast conservation therapy (BCT), which
includes breast conserving surgery (BCS) plus radiation therapy,
may be recommended. However, BCS is associated with a high rate of
re-operation with nearly one-in-five patients requiring a follow up
procedure within weeks of the initial excision to address residual
cancer.2 In addition, subsequent radiation therapy can
be cumbersome with frequent treatments over the course of several
weeks or months and the potential for a range of unpleasant side
effects. Many patients opt for a more drastic approach and undergo
a mastectomy to avoid these concerns and alleviate fears of future
reoccurrence.
Innoblative's SIRA device aims to overcome these challenges and
offer a better treatment option for BCS candidates. Its single-use,
disposable applicator is designed specifically for intraoperative
ablation of soft tissue, including potential residual cancer
post-lumpectomy. With a unique spherical shape, the SIRA electrode
circumferentially delivers radiofrequency (RF) energy to the entire
cavity and yields reproducible ablation depths to provide greater
confidence of a consistent thermal effect. Radiofrequency (RF)
ablation has been shown in multiple long-term clinical studies to
reduce reoperations and may reduce local recurrence in breast
cancer treatment. However, conventional RF devices are not
optimized to treat lumpectomy cavities and can lead to variable
treatment depths and incomplete ablations.
"Thank you to Dr. Yilmaz and his team for the seamless
completion of this first-in-human case," commented Richard Stark, CEO of Innoblative. "This is an
exciting time as Innoblative transitions to a commercial company.
We look forward to expanding upon this early clinical experience
which brings us one step closer to delivering this meaningful
technology to breast cancer patients."
About Innoblative
Innoblative is a medical device company dedicated to innovating
advanced-energy solutions that improve the way physicians treat
breast cancer and other soft tissue diseases. For more information,
visit Innoblative.com.
The SIRA® Device received FDA Breakthrough
Designation for the use in BCS and is not yet available for
sale in the United States for use
in BCS.
1Global Cancer Incidence: World Health Organization.
GLOBOCAN 2018. https://gco.iarc.fr/today/home. Accessed
9/9/2019.
2Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti
C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I,
Korourian S. Long-term results of phase II ablation after breast
lumpectomy added to extend intraoperative margins (ABLATE l) trial.
Journal of the American College of Surgeons. 2014;218(4):741-9.
doi: 10.1016/j.jamcollsurg.2013.12.032. PubMed PMID: 24655863.
Media Contact:
Charlene Herndon
Sprig Consulting
charlene@sprigconsulting.com
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SOURCE Innoblative Designs, Inc.