BioAesthetics NACgraft - Nipple-Areolar Complex Graft

Generally, women or men who are breast cancer survivors and have undergone mastectomies. Patients who have had mastectomies because of breast cancer usually cannot keep their nipples because their nipples are also cancerous or too close to the cancer. BioAesthetics designed NACgraft to give the patient a new, natural, living nipple and areola.

BioAesthetics’ NACgraft is a biologically-derived collagen-rich graft. Our patented process removes materials that can cause graft rejection, while protecting the natural proteins and structure of the NAC. Unlike traditional tissue grafts or organ transplants, where immune-suppressing drugs are required, patients who choose NACgraft will not need to take immune-suppressing drugs to support their NACgraft.

NACgrafts encourage the patient’s own cells to grow into the NACgraft where they convert the NACgraft into a living NAC. Your new NAC will look real and feel real to the touch because it’s not a prosthetic: it’s a living tissue.

NACgrafts are made with a widely-used process similar to what is used for many types of tissue grafts, which have demonstrated safety for over 30 years. Although decellularized tissues are generally considered safe, some patients may experience adverse effects or outcomes with any surgical procedure. Patients should consult with their healthcare provider about any surgical procedure they are considering.

The transition from patient to survivor is deeply personal. Returning to normalcy, or for many, a “new normal,” may include breast reconstruction. While breast mound reconstruction is now routine, a way to reconstruct the unique and complex nipple and areola has remained difficult.

Nipple Replacement
Through advancements in biomaterials, BioAesthetics is developing a safe and living nipple replacement. During breast reconstruction, your surgeon will suture BioAesthetics’ NACgraft onto your reconstructed breast. Your NACgraft will provide the foundation for your own cells to regenerate the NAC. Your new, regenerated NAC will be an enduring part of your body, and look and feel like a real nipple and areola.

NACgraft has the potential to:

• Be matched to your preferences
• Look real and feel real to the touch because it’s a natural, living NAC
• Provide long-term, aesthetic 3D nipple projection
• Require no additional or “touch up” procedures
• Require no anti-rejection medication because of minimal risk of rejection
• Add no extra recovery time to existing breast and NAC reconstruction procedures
• Enhance self-esteem and self-image
• Provide the survivor an opportunity to take more control over breast cancer and mastectomy recovery

Patients and their physicians need a NAC reconstruction option that is standardized, easy-to-apply, and aesthetically pleasing.

BioAesthetics is transforming the outcome of nipple reconstruction by bringing to market NACgraft, an off-the-shelf, biologically-derived acellular nipple-areolar complex graft. BioAesthetics’ patented method of decellularization yields a biological scaffold that retains the unique structure of the NAC and allows patients’ cells to repopulate and regenerate their own NAC. Our hope is that by providing a simpler way for patients to look and feel whole again, more patients will feel comfortable choosing to undergo a life-saving mastectomy.

Working Together to Revolutionize Breast Reconstruction
Breast reconstruction following a mastectomy is a deeply personal choice for patients. For patients who were not able to have a nipple-sparing mastectomy, NAC reconstruction remains the limiting factor for a completed breast reconstruction (1-4), although the importance of the NAC to the patient is well documented:

• NAC reconstruction is associated with improved psychosocial well-being and helps give the breast reconstruction patient a sense of completeness and closure to her cancer experience (3-7).
• The NAC may play as significant of a role in psychological well-being as the reconstructed breast mound, and some patients feel distressed after breast mound reconstruction, until NAC reconstruction (7-9).
• NAC reconstruction is highly correlated with self-esteem and improved body image, and women with reconstructed NACs score significantly higher on measures of sexual well-being, aesthetic and general satisfaction, and quality of life, as compared to women without NAC reconstruction (3, 5-10).
• While breast reconstruction techniques have been perfected, reconstruction of the NAC has remains an unmet patient need, and there is no standardized method for reliably reconstructing a living and realistic NAC (4):
• Current NAC reconstruction options include tattoos, nipple cylinder inserts, surgical skin flap reconstructions, and nipple-sharing reconstructions (6, 15) which can produce NACs that are non-permanent, do not have nipple projection, do not form distinct areolas, or fail to maintain a long-term nipple projection (1, 2, 4, 6, 10-14).
• Current surgical approaches rely on surgeons learning, practicing, and perfecting complex techniques to recreate the NAC, and show variable patient satisfaction outcomes (13-18).
• Patients may seek revision surgery if their new NACs lose projection and change in general appearance (12, 13).

Enhance Your Patients’ Overall Quality of Life
By providing your mastectomy patients with a living nipple, you will be at the forefront of a medical innovation that will advance the standard of care for your patients, enhancing their overall quality of life.

This revolutionary next step in breast reconstruction will standardize and simplify NAC reconstruction, using simple suturing to apply the NACgraft to the reconstructed breast. NACgraft will not require any additional skin from the patient. There are no complicated surgical techniques to learn, practice, and perfect. NACgraft’s ease-of-use will reduce operating time, which is best for the patient, and reduce medical facility and hospital costs.

NACgraft has the potential to:

• Be ready-to-use as needed with off-the-shelf availability
• Promote tissue regeneration and require no extra support during graft “take” period as acellular material does not need an immediate blood supply
• Require no additional recovery time to existing breast and NAC reconstruction procedures
• Maintain 3D nipple projection long-term
• Replace NAC in a single surgical procedure with no subsequent or “touch-up” procedures needed
• Free patient from taking immune-suppressing drugs, as patented decellularization process removes materials that can cause graft rejection
• Reduce surgical time by using a simple suturing technique, which should also reduce operating room costs