4D Medicine: Development of a lumpectomy device (a University spin out following ICURe)

Lead Participant: 4D MEDICINE LTD

Abstract

"Over 55,000 people in the UK are diagnosed with breast cancer annually. The original treatment is mastectomy (complete breast removal), a massively invasive surgery that causes extreme aesthetic/cosmetic changes to the patient requiring follow-up surgical procedures to remake the breast, causing this cancer to be not only physiologically but also psychologically traumatic. Tumour removal from the breast (lumpectomy) conserves the breast but significantly changes the breast's shape, and ~ 26,000 women have lumpectomies annually (UK). (Breast Cancer Care, 2017)

The most frequently used method in lumpectomy treatment is to leave an open tumour-void, with the breast's shape sustained postoperatively by the fluid-filled void. However fluid drainage causes the void to collapse and the breast to dimple or appear collapsed This may cause pain and prevent healing. Additionally, post-operative radiotherapy is difficult to precisely target, increasing the patient's risk of secondary cancer.

The emerging segment of the lumpectomy market focuses on tissue marking/void occlusion, represented best by the Biozorb device (Focal Therapeutics) (other major market players include Cianna Medical, Hologic Inc, Dune Medical Inc, and Boston Scientific). The problems with these devices, represented by Biozorb, are:

\*difficult to fit to patients: ""I can't change Biozorb's shape if I need to, I'm stuck with whatever size I've got"" (consultant oncoplastic surgeon)

\*device appeal is limited primarily to women +45-50 years due a lack of any cosmetic benefit

\*painful swelling and irritation at the implant site

4D Medicine has prototyped the 4DLUMP tissue marker and lumpectomy occlusion device to improve patient quality of life by accelerating healing and enhancing breast aesthetic/cosmetic restoration. The 4DLUMP device will:

* Maintain natural breast cosmetics
* Stimulate rapid healing and be replaced by native tissue over two years
* Improve x-ray targeting to reduce patient risk

Establishing 4DLUMP will increase patient uptake and acceptability in a younger age group, increase patient quality of life, and increase a patient's treatment options when dealing with breast cancer."

Lead Participant

Project Cost

Grant Offer

4D MEDICINE LTD £277,333 £ 190,307

Publications

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