Halscion, Inc., has announced European CE Mark approval for its Celotres™ hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing of a wound.
Scar formation is an inevitable consequence of most surgical interventions even in an age where technologies have the answer for so many hitherto unaddressed problems.
US medtech company Halscion has developed what it refers to as a “novel and proprietary” hydrogel scaffold to improve wound healing and the resulting scar consequences following suturing.
It trumpets its hydrogel as a passive scaffold comprised of biocompatible materials that provide a structural framework upon which wound healing cells, such as fibroblasts, can migrate into the wound and organise. This scaffold’s purpose is to allow the patient’s own cells to perform their typical function of propagating into the wound in an organised manner, similar to normal tissue.
The company has now gained CE Mark approval for its product, based on the results of a prospective, multi-centre, randomised, same-patient controlled, European clinical trial evaluating the efficacy of a single application of Celotres in improving wound healing and the resulting scar consequences.
One hundred female subjects undergoing laparotomy or laparoscopy gynaecologic procedures were recruited to participate in the study. Incisions or incision halves were randomised to Celotres treatment or control. Over 12 months, Celotres treated scars were demonstrated as being significantly better than control scars, as evaluated by both a surgeon observer (p=0.0051) and the subject herself (p=0.0012), using the Patient and Observer Scar Assessment Scale. Statistical significance was also demonstrated by the surgeon observer (p=0.0018) and subject (p=0.0009) when comparing a Celotres treated scar or scar half to control using the Anchored Visual Analog Scale.
“A single application of Celotres just prior to closing the surgical incision demonstrates remarkable effectiveness, from a clinical perspective, in addressing the appearance and characteristics of scarring,” said principal investigator of the study Wlodzimierz Baranowski, M.D., Professor, Department of OB-GYN, Military Medical Institute, Warsaw, Poland. “Given the lack of effective products available to physicians and patients for managing scars and the associated symptoms, I look forward to being able to use Celotres in my clinical practice.”
“We are pleased to reach this significant milestone for Halscion and look forward to making Celotres available to European physicians this year,” said Kathleen Beauchamp, President and CEO of Halscion. “Celotres will prove an important tool for physicians to consider when managing wound healing and scar outcomes.”
Come on Halscion, show us the paper. We’re a sceptical bunch here and until we see the evidence we’ll reserve judgment. What’s the hypothesis here? It’s all very well bandying words like “proprietary” and “biocompatible materials” around, but unless we see some substance behind the “better” results we’ll assume it’s magic dust combined with care-related variables.
Also, we need to define the word better… we cannot help but wonder what the patients are thinking about their schizophrenic semi-perfect wounds, unless better means “just a bit better”.
It looks like really interesting work, but this is a huge subject with a long history and an entire specialism behind it. One study and a CE mark has to be the start rather than the conclusion to what may be an interesting story.
Note: Celotres is an investigational device, limited by federal law to investigational use in the United States.
Source: Halscion Inc., Business Wire