Clinical Data
The bio-ConneKt® Wound Matrix, an FDA cleared advance wound care product is manufactured and distributed by MLM Biologics, a Gainesville, FL based medical device company. It is a versatile device that is indicated for the treatment of a variety of skin breaches (acute, chronic, traumatic, surgical, decubitus, Post-Mohs, burns). With more than a hundred different options in the marketplace, clinicians and administrators constantly face trade-offs on quality, efficacy, pricing, and logistics when selecting an ideal wound care treatment option. Here is how the MLM option can successfully address these challenges:
The bio-ConneKt® wound matrix is marketed as a terminally sterile product that is manufactured in an ISO 13487 certified facility. The product boasts over 6 years of adverse event free history, and successful outcomes from multiple audits including the FDA, in light of the industry best quality control steps and a smart manufacturing environment implemented by the company.
bio-ConneKt® has helped heal more than 2000 wounds successfully, often as a single application of the product considering the company’s collagen stabilization technology. The product offers one of the industry’s best option for complementary wound treatment, as a delivery option (antibiotics, antimicrobials, growth factors), as-well an adjunct concurrently with NPWT (due to the porous and mechanically robust architecture). Designed to eliminate repeat applications, bio-ConneKt® is an especially timely option now, as it minimizes patient re-visits to the clinic and supports social distancing from a clinical perspective.
Being a room-temperature stored product with a 4-year shelf life, bio-ConneKt® offers easy storage and inventorying across the wound care provider continuum (doctor’s office, ASC, in-hospital, LTACHs, SNFs, home health care, etc,). With a short prep time (no specific side selection, brief hydration), and with the ability to cooperatively work with all other wound care sundries, it improves operating room efficiency for the clinical team (no “last mile” problems). An “in-person” technical or administrative assistance (no sales representative or automated phone messages) from the company is available 24/7.
The company also encourages institutions to assess the medical-economic advantage of bio-ConneKt® by freely participating in trial use of the product or submitting to a head-to-head total wound closure cost with any other product.
bio-ConneKt® is eligible for Medicare Administrative Contractor (MAC) Part B coverage in all 50 states. We can offer assistance with reimbursement and billing related queries to ensure reimbursement for the product in a doctor’s office or at a surgery center. Please send your queries for assistance to contact@biowound.com.
CMS HCPCS CODE: Q 4161
bio-ConneKt® wound matrix has been assigned to the CMS high-cost reimbursement group effective April 1st, 2017.
- CATALOG #: 1101-1515 1.5cm x 1.5cm Billing units = 2
- CATALOG #: 1101-0202 2cm x 2cm Billing units = 4
- CATALOG #: 1101-0303 3cm x 3cm Billing units = 9
- CATALOG #: 1101-0404 4cm x 4cm Billing units = 16
- CATALOG #: 1101-0505 5cm x 5cm Billing units = 25
- CATALOG #: 1101-0607 6cm x 7cm Billing units =42
- CATALOG #: 1101-0126 6cm x 21cm Billing units = 126