Otolaryngology

EpiPatch™, SeptoPatch™, MyringoPatch™, SeptumSegment™

Effective tissue repair in otolaryngology demands materials that integrate seamlessly with delicate anatomical structures while supporting natural healing. NovioTissue’s ENT solutions are developed to assist surgeons in tympanic membrane repair, septal reconstruction, and mucosal regeneration. These biologically compatible grafts are designed to conform to complex anatomy, encourage tissue integration, and support predictable healing—helping restore function while preserving structural integrity in ENT procedures.

Purpose-Built Solutions for Delicate ENT Tissue Repair and Reconstruction

The need for a reliable, high-quality alternative has never been greater. EpiPatch is the next-generation solution, providing an effective and compliant option for tympanic membrane repair. The repair system offers a versatile solution adaptable to different shapes and sizes of perforations. Its simplified procedure allows for in-office application under local anesthesia, eliminating the need for operating rooms and general anesthesia. 

Key Advantages:

✅ Ultra-thin (<0.1 mm), ensuring a natural fit and seamless integration.
✅ Bioactive properties that promote healing and minimize scarring.
✅ Ready-to-use, simplifying application and post-operative care.

Noviotissue’s EpiPatch, is developed from human amniotic tissue, selected for its natural elasticity and protective capabilities. This tissue, obtained following cesarean deliveries, undergoes decellularization to preserve its extracellular matrix (ECM).

These products comply with EU guidelines, emphasizing their role as protective barriers that maintain elasticity, mirroring the amniotic tissue’s natural function. The decellularization process employs supercritical CO2 technology, which maintains the amniotic membrane’s structure and function, thus optimizing its therapeutic efficacy.

EpiPatch’s thinness, less than 0.1 mm, allows it to serve as a bioactive wound dressing that adheres upon contact, simplifying postoperative care, and is valued for its ease of use and storage.

Regulatory Excellence and Clinical Versatility​

EpiPatch adheres to European regulatory standards, ensuring its safety and effectiveness as a biologic graft. Manufactured using supercritical CO₂ decellularization technology, it retains the structural integrity and elasticity of the amniotic membrane, optimizing its therapeutic benefits.

Effective for revision cases, it provides a minimally invasive option for cases with residual or recurrent perforations. Constructed from amnion extracellular matrix, in clinical studies it showed it promotes natural healing processes with high tensile strength, durability, and elasticity. The system’s adhesive properties ensure secure coverage, while its protective barrier aids in wound recovery. With no preparation required, it simplifies the treatment process, making it a convenient and effective choice for patients and clinicians alike.

“Flexibly fitting all shapes and sizes for seamless tympanic membrane repair.”

EpiPatch In-Action

Video credit to our U.S. partners BioMed/BioMed ENT

The bony surface was in a slightly wet state from blood or effusion.

TA piece of the hyperdry AM was cut to the required size.

Hyperdry AM was slightly pressed to stick firmly to the bony surface (arrows).

Download the Product Brochure for More Information!

EpiPatch is a sterile, dehydrated human amniotic membrane (dHAM) allograft used as a biologic support in otologic surgery. Sourced from donated placental tissue, EpiPatch retains the natural extracellular matrix to promote epithelial regeneration, reduce inflammation, and support healing. It is ideal for tympanoplasty, mastoid cavity lining, cochlear implant surgeries, canal wall reconstruction, and cholesteatoma resections. Applied dry and naturally resorbed by the body, EpiPatch conforms easily to anatomical structures without requiring graft harvest, offering a versatile, shelf-stable solution for ENT surgeons seeking biologically active wound coverage.

Novio-EpiPatch Brochure_Thumb

Human Donor Fascia Lata for Septal Perforation Repair

Nasal septal perforation repair is widely recognized in the published literature as a technically demanding procedure with variable outcomes. Reports describe success rates that differ significantly based on perforation size, tissue quality, surgical technique, and graft selection.
 
SeptoPatch is a human donor fascia lata patch developed to provide surgeons with a standardized biologic graft option intended for use in septal perforation repair.

A Biologic Graft Option for a Complex Surgical Challenge

Typical Septal Perforation Repair Technique (Illustrative)

Published surgical techniques commonly describe septal perforation repair using bilateral mucosal flap elevation with placement of an interposition graft between the flaps.
 
In this approach, mucoperichondrial flaps are carefully elevated on each side of the septum while preserving blood supply. An interposition graft is then positioned between the flaps to span the perforation. The graft serves as a biologic scaffold and structural layer while the mucosal flaps are advanced and closed over it. Internal support, such as nasal splints or temporary stabilization, may be used during the healing phase.
 
This multilayer configuration is described in the literature for small, moderate, and selected large septal perforations and is intended to reduce tension at the repair site while supporting mucosal healing.
 
SeptoPatch is designed for use as an interposition graft within this commonly described repair framework.

Why Are Septal Perforation Repairs Challenging?​

Published studies describe multiple factors that contribute to the complexity of septal perforation repair, including:
  • Limited availability of healthy mucosal tissue
  • Reduced vascularity, often related to prior nasal surgery
  • High tension at closure sites
  • Larger or irregular defects
  • Scarred or fragile septal tissue
The literature suggests that these factors may contribute to inconsistent closure rates and have led some surgeons to favor conservative management over surgical repair in selected cases.

Potential Clinical Considerations

Clinical literature suggests that the use of an interposition graft may be associated with improved closure rates compared to flap-only techniques in septal perforation repair. Interposition grafts are described as providing:
Multiple published studies have evaluated fascia-based grafts as interposition materials in this setting.

Why Fascia Lata?

Human fascia lata has been described in the literature as a commonly used biologic graft in reconstructive procedures. Studies suggest that fascia lata offers a combination of tensile strength, flexibility, and handling characteristics that may be favorable for septal repair applications.
 
Published reports evaluating donor and autologous fascia lata in septal perforation repair have described closure rates in the range of approximately 80–90 percent in selected patient populations, including larger defects, when used as part of multilayer repair techniques.
 
These findings reflect reported outcomes in the literature and may vary based on surgical technique, patient factors, and defect characteristics.

SeptoPatch Design Rationale

SeptoPatch standardizes human donor fascia lata into a configuration selected for septal perforation repair.
 
Product Specifications:
The dimensions are intended to allow surgeons to trim the graft to match defect geometry while maintaining adequate surface area for coverage.

Potential Clinical Considerations

Based on published literature and reported surgical experience, donor fascia lata grafts have been described as offering:
Use of SeptoPatch does not alter the technical demands of septal perforation repair, which remain dependent on surgeon technique, tissue quality, and patient-specific factors.

Comparison to Commonly Described Alternatives

The literature describes several graft materials used in septal perforation repair, including autologous fascia, cartilage, acellular dermal matrices, and synthetic supports. Studies suggest that each material presents tradeoffs related to handling, availability, and integration.
 
Fascia lata has been described as offering a balance of strength and flexibility without the additional operative steps required for autologous tissue harvest.

Intended Use

SeptoPatch is intended for use by qualified healthcare professionals as a soft-tissue interposition or reinforcement graft in nasal septal perforation repair.

Important Note

The clinical outcomes associated with septal perforation repair vary widely and depend on multiple factors. The information presented reflects findings reported in the published literature and is provided for educational purposes only. Individual patient outcomes may vary.

Not every tympanic membrane perforation requires surgery. MyringoPatch provides an innovative solution for patients who need an effective, reconstructive approach to healing. MyringoPatch is engineered to eliminate the need for a second surgery site, ensuring optimal surgical outcomes without compromise. With these advantages, MyringoPatch represents a significant advancement in the treatment of tympanic membrane perforations, offering patients a safer and more reliable healing journey.

Key Advantages:

✅ Customizable for various perforation sizes and shapes, reducing the need for surgical intervention
✅ Supports natural tissue regeneration, providing a safe and effective healing process
✅ Structural support for more complex tissue regeneration in middle ear surgery or septoplasty

“The Safe Alternative To Autologous Fascia Temporalis”

Regulatory Excellence and Clinical Versatility

MyringoPatch meets European regulatory standards, ensuring safety and reliability. Designed as a bioactive graft, it supports natural healing while minimizing patient discomfort. Just a few clinical benefits include:

  • Suturable Design: Its unique composition allows for direct suturing, enabling a precise placement and secure fixation during the healing period.
  • Proven Clinical Success: MyringoPatch has demonstrated excellent clinical results, underscoring its reliability and effectiveness in patient care.
  • Minimized Risk: By avoiding a secondary surgery site, MyringoPatch significantly reduces the chances of infection and scarring, promoting a smoother recovery process.
  • Enhanced Mechanical Strength: MyringoPatch is crafted for durability, offering superior resistance to facilitate effective healing.

10-Week Healing Progression – Before (Left) After (Right)

CaseStudies

Tympanic membrane perforations vary significantly in shape and size, stemming from a multitude of causes. While complex cases often necessitate an underlay procedure conducted in the operating room under general anesthesia, not all situations require such extensive measures. Successful interventions may still result in residual or recurrent perforations, and for these revision cases—as well as some primary perforations of limited size—an in-office procedure with a transcranial overlay under local anesthesia is adequate. For these instances, EpiPatch presents a biological solution, acting as a protective bandage to cover and safeguard the surgical area, streamlining the healing process without the need for operating room facilities.

Harvinder S, Hassan S, Sidek DS, Hamzah M, Samsudin AR, Philip R.
Underlay myringoplasty: comparison of Human Amniotic membrane to temporalis fascia graft.
Med J Malaysia. 2005 Dec; 60(5):585-9 PMID: 16515109
https://pubmed.ncbi.nlm.nih.gov/16515109/

Yung, M., Vivekanandan, S., Smith, P.
Randomized study comparing fascia and cartilage grafts in myringoplasty.
Ann. Otol. Rhinol. Laryngol, 2011; 120:535Y41
https://pubmed.ncbi.nlm.nih.gov/21922978/

Jalali. M.M., e.a.
Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies
Laryngoscope, 2017; 127:2139-2148
https://pubmed.ncbi.nlm.nih.gov/27933630/

Download the Product Brochure for More Information!

MyringoPatch is a sterile, freeze-dried fascia lata allograft designed for structural repair in ENT procedures without the need to harvest autologous fascia. Engineered to maintain its tensile integrity and resist degradation, it’s a preferred graft for tympanic membrane repair, mastoid cavity lining, nasal septal reconstruction, and endoscopic skull base applications. MyringoPatch provides a strong collagen scaffold that supports epithelialization and closure of even large or revision-site perforations. Backed by decades of clinical use, this human-derived product is shelf-stable, easy to handle, and proven effective across a wide range of otolaryngologic and neurosurgical indications.

Novio-MyringoPatch Brochure_Thumb

The SeptumSegment offers a biologic alternative to autologous tissue grafts, providing surgeons with a ready-to-use solution that enhances procedural efficiency and patient outcomes. The SeptumSegment stands out as a preferred material for rhinoplasty, offering fully customizable shaping to ensure an ideal fit for each patient.

Key Advantages:

✅ Available in multiple sizes for tailored surgical applications.
✅ Reduces surgical time by eliminating the need for autologous graft harvesting.
✅ Supports predictable healing and long-term structural stability.

“The premier choice for replacing autologous tissue in rhinoplasty procedures.”

Regulatory Excellence and Clinical Versatility

SeptumSegment meets European regulatory standards and is available in saline as a on-the-shelf option and fresh-frozen formats, accommodating various surgical needs. Its biocompatible structure allows for seamless integration while maintaining structural integrity.

This versatility streamlines the surgical process and accommodates diverse clinical requirement. Its proven effectiveness, supported by positive clinical outcomes, underscores its reliability and performance in surgical applications.

Septum Segment In-Action

Video credit to our U.S. partners BioMed/BioMed ENT

CaseStudies

SeptumSegment represents an innovative solution in rhinoplasty, offering precisely sized costal cartilage for both primary and complex surgical procedures. For decades, cartilage has been recognized as a safe and effective substitute for autologous grafts or synthetic materials, boasting high biocompatibility. SeptumSegment stands out for its consistent quality, with studies indicating low complication rates [1], ensuring reliable functional, structural, and cosmetic outcomes with minimal adverse effects [2].

This product underscores its value in cases where patients lack sufficient or high-quality cartilage, serving as an optimal alternative. Clinical evidence highlights the advantages of SeptumSegment over autologous grafts, notably avoiding the additional risks associated with secondary donor sites, such as extended anesthesia and increased infection potential.

Designed for immediate application, SeptumSegment can be tailored to any required dimensions, facilitating a safe and efficient rhinoplasty process. Available in two length variations—over 15 mm and over 30 mm—and in both freeze-dried and fresh-frozen formats, SeptumSegment is a versatile and dependable choice for enhancing patient outcomes in rhinoplasty surgeries.

SeptumSegment represents a fusion of innovation and clinical utility. Medical devices, as outlined by the FD&C Act, are essential tools ranging from diagnostic instruments to implants. Unlike these devices, biologics—categorized as tissues and cellular-based products—are poised for human therapeutic use and can garner additional reimbursement when billed under the unlisted CPT Code 17999.

[1] Menger, D.J, Nolst Trinete, G.J.,
Arch Facial Plastic Surg. 2010; 12 (2): 114-118.
https://biomed-ent.com/rhinoplasty-solutions/#_ftnref1

[2] Kridel, R.W., e.a.
Long-term use and follow-up of irradiated homologous costal cartilage grafts in the nose. Arch Facial Plast Surgery, 2009; 11 (6): 378-394.
https://biomed-ent.com/rhinoplasty-solutions/#_ftnref2

Download the Product Brochure for More Information!

SeptumSegment is a biocompatible cartilage graft alternative designed specifically for rhinoplasty and nasal reconstruction. Available in fresh frozen or freeze-dried formats, it eliminates the need for autologous cartilage harvest, reducing patient discomfort and surgical time. This versatile implant can be custom-shaped to fit individual anatomical needs and is ideal for correcting nasal obstructions or enhancing nasal aesthetics. Surgeons benefit from its ready-to-use format and reliable performance, making SeptumSegment a dependable option for both functional and cosmetic nasal surgeries.

Novio-SeptumSegment Brochure_Thumb

Order Information

Use the following information when filling out your purchase order. To obtain individual/box-quantity pricing, or to submit a purchase order, contact your local distributor. To find a local distributor, submit a contact form on our contact us page.

Code

Description

Diameter / Dimensions

Thickness

NT2108FD

EpiPatch* Disc – S, Freeze Dried

8 MM

0.1 MM

NT2110FD

EpiPatch* – M, Freeze Dried

10 x 10 MM

0.1 MM

NT2010FD

EpiPatch* Disc – M, Freeze Dried

10 MM

0.1 MM

NT2012FD

EpiPatch* Disc – L, Freeze Dried

12 MM

0.1 MM

NT2120FD

EpiPatch* – L, Freeze Dried

20 x 20 MM

0.1 MM

NT2016FD

EpiPatch* Disc – XL, Freeze Dried

16 MM

0.1 MM

NT2060FD

EpiPatch* – XL, Freeze Dried

20 x 30 MM

0.1 MM

NT4030FD

SeptoPatch – Freeze Dried

30 x 30 MM

Greater than 0.2 MM

NT1010FD

MyringoPatch – M, Freeze Dried

10 MM

0.2 MM

NT1016FD

MyringoPatch – L, Freeze Dried

16 MM

0.2 MM

NT1030FD

MyringoPatch – XL, Freeze Dried

25 x 30 MM

0.2 MM

BEN3030FF

SeptumSegment – S,

Fresh Frozen Cartilage

8 – 10 MM

Less than 5 CM

BEN3031LI

SeptumSegment – S,

Lyophilized Cartilage

8 – 10 MM

Less than 5 CM

BEN3040FF

SeptumSegment – M,

Fresh Frozen Cartilage

8 – 10 MM

5 – 8 CM

BEN3041LI

SeptumSegment – M,

Lyophilized Cartilage

8 – 10 MM

5 – 8 CM

BEN3050FF

SeptumSegment – L,

Fresh Frozen Cartilage

8 – 10 MM

Greater than 8 CM

BEN3051LI

SeptumSegment – L,

Lyophilized Cartilage

8 – 10 MM

Greater than 8 CM

* Medtronic EpiDisc and EpiFilm Replacement