The Operating Theatre Journal - Flipbook - Page 20
Signum Surgical Completes Clinical Trial for BioHealxTM
Ø Galway based company compiling data for submission of a De Novo classi昀椀cation request to U.S. FDA
Ø Novel surgical option for the treatment of anal 昀椀stula, a painful and debilitating colorectal condition
Signum Surgical, (‘Signum’ or ‘the Company’) the clinical stage
medical technology company developing innovative solutions to treat
colorectal diseases, announces the completion of its single-arm, nonrandomized, clinical trial to evaluate the safety and ef昀椀cacy of its
BioHealxTM device for the treatment of anal 昀椀stula.
The multi-centre
clinical trial, led by
four investigators, treated
a total of 32 patients in the adult
male and female patient population with
BioHealxTM, who had experienced recurrent
anal 昀椀stula from at least one previous failed procedure.
Final follow up assessments have been completed on the 32
patients over a period ranging from 13 to 40 months. This clinical
trial data is currently being compiled for submission of a De Novo
classi昀椀cation request to the U.S. Food and Drug Administration (FDA)
and scienti昀椀c publication in due course, which would pave the way for
bringing BioHealxTM to market.
As a novel treatment option, with no legally marketed predicate
device, Signum Surgical will submit a De Novo request to classify
BioHealxTM,. A DeNovo request is a risk-based classi昀椀cation process
for which general controls alone, or general and special controls,
provide reasonable assurances of the safety and ef昀椀cacy for its use in
the treatment of anal 昀椀stula.
Peter Ónody, Colorectal Surgeon and Principal Investigator of the
clinical trial, commented:
“I am excited at the potential of BioHealxTM as a novel surgical
option for the treatment of anal 昀椀stula and, in particular, its ease of
use for physicians. This treatment has the potential to eliminate the
need for multiple surgeries and substantially reduce surgical trauma
and the rate of 昀椀stula recurrence, while reducing costs for patients
and the overall health care system.”
Pictured (L-R): Moshe Zilversmit, co-founder and CEO with Signum
Surgical scienti昀椀c advisory board member Mark Regan, M.D., and
Eoin Bambury, co-founder and chief technology of昀椀cer pictured
holding the BioHealx Technology.
Moshe Zilversmit, Co-Founder and CEO of Signum Surgical,
commented:
“The completion of our clinical trial marks a signi昀椀cant milestone
for Signum Surgical and our BioHealxTM device. We look forward to
submitting our De Novo classi昀椀cation request to the U.S. FDA and the
scienti昀椀c publication of the data in due course, as we seek to bring
this novel treatment to market for the bene昀椀t of patients, surgeons,
and the healthcare system.”
Headquartered in Galway, Ireland, Signum Surgical is a clinical
stage, ISO 13485 certi昀椀ed, company focused on developing minimally
invasive technologies to treat colorectal diseases, 昀椀rstly introducing
the BioHealx™ technology to address the treatment of anal 昀椀stula.
This painful colorectal condition affects one in 5,000 people
worldwide1 and in the United States over 90,000 surgeries are
performed annually to treat anal 昀椀stula2. Current treatment options
are often unsuccessful, which frequently result in inadequate or slow
healing, a high risk of incontinence, and repeat procedures.
Developed in collaboration with expert colorectal surgeons,
BioHealxTM will enable surgeons to treat anal 昀椀stula with a minimally
invasive outpatient procedure, featuring a single use, bioabsorbable
implant that is designed to close the 昀椀stula tract and dissolve in the
body after treatment. The single-operation approach is designed
to promote healing, prevent 昀椀stula recurrence, and protect patient
continence.
Save The Date
Shef昀椀eld Hallam University
ODP Conference
For more information, please visit:
https://www.signumsurgical.com
References:
1 Ommer A et al: Clinical practice guideline: Cryptoglandular anal
昀椀stula Deutsches Arzteblatt International 2011; 108(42): 707–13.
31st May 2024
More information coming soon!
https://www.researchgate.net/publication/51826318_
Cryptoglandular_Anal_Fistulas
2 Zanotti, C., Martinez-Puente, C., Pascual, I. et al. Int J Colorectal
Dis (2007) 22: 1459
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