BRIGHTMEM CORNEAL ALLOGRAFT
FIELD EDUCATION & EXECUTION GUIDE

In This Guide

In this Field Guide you will find training resources for surgeons, overview and talking points about BrightMEM, ordering instructions, FAQs, patient identification tips, and more. If you have any questions, please contact

For Surgical & Education Questions:

Jared Young jared@brightstartx.com 619-518-0734

 For Operational Questions:

Rusty Kelly

rusty@brightstartx.com

415-254-5818

Surgeon Registration:

To register a new surgeon as a BrightMEM provider, please direct them to or help them fill out the form here: Surgeon Registration

Having surgeons register will provide them with a direct link to the surgeon training, including video and surgical pearls, as well as a link to schedule a call with Dr. Tauber.


BrightMEM Overview / Talking Points

 

BrightMEM Description

  • BrightMEM is an innovative corneal allograft composed of Descemet’s Membrane that promotes corneal re-epithelialization and functions as a robust basement membrane with natural long-term durability – representing a new treatment for patients with impaired corneal healing.

  • BrightMEM is a minimally manipulated donor corneal tissue that is available via Brightstar Therapeutics and distributed by partner eye banks.

  • BrightMEM is reimbursable under CPT 65710 for anterior lamellar keratoplasty (ALK) and the tissue is reimbursed at invoice cost using V code 2785.

 

Preclinical studies conducted by Dr. Joshua Hou at the University of Minnesota demonstrate that:

  • Descemet’s membrane is optically clear and resistant to collagenase digestion.

  • The anterior fetal banded layer of Descemet’s membrane expresses limbal basement membrane-specific proteins.

  • Descemet’s membrane can serve as a long-term substrate for the corneal epithelium, supporting the proliferation of limbal stem/progenitor cells (LSPCs).

 

BrightMEM Value Proposition

  • Acellular corneal graft made from a durable basement membrane (Descemet’s Membrane)

  • Provides limbal niche-like environment on ocular surface

  • Supports limbal stem cell health and epithelial proliferation

  • More durable compared to amniotic membrane grafts

  • Optically clear graft maintains corneal transparency

  • Simple transplantation procedure familiar to anterior segment surgeons

 BrightMEM Clinical Background

Conditions Affecting the Epithelium

  • Persistent Corneal Epithelial Defect

    • A persistent corneal epithelial defect (PCED) occurs when there is a failure of re-epithelialization after a corneal injury. According to recent estimates, there are approximately 97,000 cases of PCED a year in the United States

    • Damage to the epithelial basement membrane, the substrate  that supports healthy epithelial cells, can lead to recurrent corneal erosions.

    • Patients suffer significant symptoms including pain, redness, and photophobia and often develop complications including corneal neovascularization, infection, opacification, and subsequent vision loss. Serious complications, including corneal ulcers, corneal perforation, irreversible scarring, melting, and lifelong recurrent corneal erosions impact a significant number of patients.

  • Limbal Stem Cell Deficiency

  • Limbal stem cell deficiency (LSCD) is difficult to diagnose due to comorbid diseases and overlapping symptoms with more common diseases, often resulting in delayed treatment.

  • The prevalence of LSCD in the U.S. is approximately 165,000 cases per year, as reported by orphanet.net.

  • LSCD can be congenital in patients with aniridia, keratitis associated with multiple endocrine deficiency, dyskeratosis congenital, and epidermal dysplasia.

  • Common causes of acquired LSCD include chemical and thermal burns, ocular surgeries involving the limbal region, contact lens overwear, and chronic ocular surface inflammatory diseases. Immunologic diseases such as Stevens-Johnson syndrome and mucous membrane pemphigoid are also known to lead to LSCD.

Current Treatment Options

Persistent corneal epithelial defects (PCEDs) and limbal stem cell deficiency (LSCD) are challenging corneal diseases with limited long-term treatment options currently.

Overview of Descemet’s Membrane Anterior Keratoplasty Procedure with BrightMEM Corneal Allograft

About the Graft

  • The product is aseptically processed from tissues obtained from donated human tissue (corneas) according to the current Good Tissue Practices (cGTP) regulations established by the US Food & Drug Administration (FDA).  Please see the product insert for more information.

    • The graft only contains the two layers of DM (anterior or fetal banded layer and the non-banded layer)

    • It is acellular.  All the endothelial cells have been removed.

    • The BrightMEM graft remains hinged to the scleral rim 1.5 millimeters from the limbus.

    • The BrightMEM comes in viewing chamber in tissue storage solution.

    • It is approximately 15 microns thick.

    • It is stored and handled like fresh tissue (see product insert for details).

       

Presenting Data and Clinical Experiences

Pre-clinical data highlights

  • BrightMEM expresses limbal basement membrane specific proteins

  • Demonstrates limbal stem cell and epithelium support and protection from stromal melting

  • Supports maintenance & proliferation of Limbal Epithelial Stem Cells (LESCs) as demonstrated by biomarker expression

  • Maintains a population LESCs in the basal corneal epithelium

  • Collagenase degradation assay demonstrated that BrightMEM was more resistant to degradation than amnion

 Clinical Experience

  • Approximately 90% of cases reported were fully healed within a mean healing time of 34.5 days

  • For patients with follow-up care after 12 months, 100% reported complete re-epithelization

  • More than half reported improved vision within a month – and vision reportedly continues to improve with time

  • A successful graft retention rate of 92.7%

  • Significant improvement in limbal cell growth demonstrated by an improved central staining grade from 3.2+ to 2.2+

  • Neovascularization drops from an average of 71.4% to just 5.8%

  • No infectious, inflammatory or rejection complications were reported

Ideal Patients

  • For a surgeon’s first few cases, avoid choosing severe ocular surface problems, particularly cases with active inflammation, stromal edema, uncontrolled IOP or insufficient fornix depth to allow bandage contact lens fitting.

  • Non-healing corneal epithelial defect

  • Herpes Zoster epitheliopathy

  • Partial limbal stem cell deficiency (≤75%) with or without epithelial defect

  • Post-infectious / post-operative Neurotrophic keratitis

  • Chronic epitheliopathy

  • Medicamentosa / toxicity / Contact Lens (CL) overuse LSCD

Addressing Physician Concerns

  • When should a surgeon perform BMAK?

    • Suspected LSCD but non-candidate for systemic immunosuppressive therapy

    • Better visualization through clear cornea would affect treatment decisions

    • PED persists despite above treatments (typically > 2 weeks)

    • Amniotic membrane has failed or degraded rapidly (< 10 days)

    • Stromal melting / thinning is evident

    • Limbal stem cell deficiency is present or suspected

    • The PED is large (> 4-5 mm) or centrally located

    • History of prior or recurrent PEDs

    • There is significant ocular pain

  • I have a different patient. Is BrightMEM Good For…..

    • For indication-specific questions that are not addressed in the guide, please contact Dr. Tauber at 913-558-4230.

    • Additionally, Brightstar Therapeutics has developed a Persistent Corneal Epithelial Defect (PCED) Algorithm to help surgeons identify ideal patients for BrightMEM. It is available on the Surgeon Training webpage

  • How Do I Order?

    • Order from your preferred eye bank partner the same way order a DMEK or DSEK.

  • How Early Do I Need to Order?

    • We kindly ask that surgeons place their order 7-10 days before their scheduled surgery

  • How Long Does the Tissue Last?

    • BrightMEM is fresh donated corneal tissue. It is rated in storage media to last for 14 days. Tissue is delivered to the eye bank or surgery center the day of or up to 2 days before surgery. We always coordinate the delivery time with the eye bank.

  • How Long Does the Procedure Take?

    • This varies depending on a number of factors, but after the Superficial Keratectomy is performed, we find most doctors can complete the BrightMEM procedure in less than 20 minutes.

  • Is It Reimbursed?

    • Yes! The CPT Code is 65710 and the tissue code is V2785

    • ICD-10 Codes are available for sharing.

    • Full Reimbursement Guide is available on the website

    • For further issues not addressed in the guide, direct them to complete our reimbursement help form at https://www.brightstartx.com/reimbursement-help-form

  • Clinical Questions About Treatment or Outcomes

    • Share preclinical studies that address their concerns.

    • Share case series or individual cases with the doctor that may match the patient’s circumstances.

    • Share the Clinical Support Data Summary (available on the Surgeon Training webpage)

    • Set up a meeting between the doctor and our medical affairs team.

    • Make an email introduction to Joe Tauber.

  • Clinical Questions about the Surgical Procedure

    • Share the training video and instructions, including surgical pearls.

    • Set up a meeting between the doctor and our medical affairs team.

    • Make an email introduction to Joe Tauber and/or Joshua Hou.

  • Clinical Questions with the Tissue Pre-operation

    • Share the training video and instructions, including tips and tricks.

    • For specific needs (e.g., size of the graft), contact Brian Philippy at LGS.

    • For usage-related questions, have the surgeon send an email to our medical affairs team.

  • Clinical Questions about the Surgical Procedure (During Procedure or Post-op)

    • Have the surgeon send an email to our medical affairs team.

    • For urgent matters, call Dr. Tauber at 913-558-4230.

Call to Action

The focus should be on education, developing trust, and supporting a positive initial experience for the surgeon to adopt BrightMEM.

In our experience, many surgeons are already aware of BrightMEM but are not sure of who to select as a first patient. When they do encounter good patients, BrightMEM may not be top-of-mind at the moment. Some ideas that could help:

  • Stay in contact with your surgeons to keep BrightMEM top-of-mind when they are in their clinic

  • Ask if you can attend a surgery; pick a day so they have time to find patients

  • Offer to be available via video or audio call during their procedure, if not attending live surgery

  • Send reminders for all educational opportunities offered via Brightstar Therapeutics (wet labs, demonstrations, webinars, etc.)

  • Offer to connect them with other doctors who have done a BrightMEM that they may know

  • Talk to them about other cases you know of (ie: “We had a doctor recently who used a BrightMEM on a Neurotrophic Keratitis (NK) with a great result. If you’d like to talk to her, I’d be happy to connect you!”)

  • You may also always connect them with Dr. Tauber or Jared Young for support at any time

Follow-Up Recommendations:

  • Via Email

    • Introduce surgeon to BrightMEM with brochure and link to training video.

    • If interested and has questions

      • Set up a meeting with Medical Affairs team (Joe or Josh)

      • Set up a meeting with Jared

      • Suggest that they identify a few patients to use BrightMEM

  • Follow-up If no response

      • Attempt #2 should share case studies and an offer to speak with our medical affairs team

      • Attempt #3 should share our white paper and invites to any upcoming educational events, like webinars or trade shows (wet labs and demonstrations)

      • Make sure all these emails are BCC to HubSpot or manually logged into HubSpot

  • In-Person

    • Introduce the surgeon to:

      • BrightMEM allografts

      • Clinical experience

      • Patients that BrightMEM might help

    • Discuss if they have any patients that could be helped by BrightMEM

    • Would they like to use BrightMEM with a patient

    • If they need to speak with a medical professional, offer a meeting with Drs. Tauber and Hou

    • Make sure to leave behind information on how to order

    • Make sure to log your visit into HubSpot 

  • In-Person Follow-up

    • Email with a recap of the conversation and confirm a meeting with medical affairs if requested and the link to register as a provider

    • If no response after two weeks, send an email to give an update on any upcoming educational events, such as a webinar or wet lab

    • If no response after a month, work with Jared or Dr. Tauber to have them reach out via email

  • If surgeon requests a BrightMEM (first order)

      • Have surgeon register as a provider (this triggers an email containing training video and link to schedule a call with Dr. Tauber)

      • Stress to them the importance of setting up a call with Dr. Tauber or Dr. Hou before their first case

      • Brightstar will send an automated email when the request is entered into Jotform and then again three days prior to the surgical date with the same information about preparing for the surgery

      • Rep should reach out to the surgeon the day after the surgery to inquire how it went – address any challenges or concerns (please log in HubSpot)

      • Keep touch with surgeon to learn how BrightMEM is working for their patient and if they would be interested in writing a case report

      • Brightstar will send an automated email to surgeon 30 days post op to provide them with the outcomes report form to complete