Tarsus Patch in Cold Seal 1

Eyelid Patch in cold seal.

Tarsus_Eyelid_Patch_crop

Front of patch with lines to aid in application alignment.

Tarsus_Eyelid_Patch_Back_crop

Release liner on the back of patch with directional arrows to remove.

Applied Patch New

Applied Eyelid Patch.

Tarsus Eyelid Patch 

The Tarsus Eyelid Patch is ideal for attaining eyelid closure for many applications, such as encouraging the healing corneal abrasions and injuries, preventing corneal erosion due to exposure, addressing lazy eye, nocturnal use for stroke survivors, and those with bell’s palsy, or those who suffer from dry eyes due to lagophthalmos. There is also a big need in the ICU for those in medically induced comas, as well as during and after surgeries, addressing keratopathy, and for the elderly with eye health complications. This product also can be used in tandem with Prokera therapy and other products or medicines that require sustained eyelid closure as a part of the therapy.

The patented Tarsus Eyelid Patch is an innovative eyelid closure device and method, which utilizes the strengths of adhesion, structure, curvature and resistance. It is an affordable therapeutic that will transform cornea care and replace antiquated eyelid closure devices and techniques. Using design, simple mechanics, and the most advanced materials and adhesives, the Tarsus Eyelid Patch stands alone in effectiveness and patient comfort.

 

Click the link to see the clinical trials of the Nictavi Tarsus Eyelid Patch that were conducted at the Children's Hospital of Los Angeles. https://youtu.be/1jxqo9IIiU0

 

Prototype Designs

Product Development

For 6 years the Tarsus Eyelid Patch was in development. Various iterations have been created, with slightly different features. After applied use by the inventor, he has come up with a harmony of the various features and has found the best adhesives and materials that behave as desired to enable the device to perform its function of comfortable, effective eyelid closure.

 

 

 

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Directions for application and removal of the Tarsus Eyelid Patch.     

Eyelid surface must be clean and dry before applying patch.

1. Apply centered on closed upper eyelid, above the eye opening and lashes. Rub gently to adhere. Fig A

 

2. To remove, roll your finger gently over either side edge of the patch, rolling back a portion. Grab the portion with your fingers and gently peel the patch off.

 

Why Us? / How it works

The Tarsus Eyelid Patch is an elongated octagon shape with rounded corners. It has many unique features that make it superior the other eyelid closure product options. Our product is made of breathable medical materials. It has a gentle yet aggressive adhesive that holds fast on the sensitive skin of the eyelid and removes without irritation or residue. It is comfortable and effective to wear for long periods of time. It can be worn during sleep to sustain eyelid closure when addressing nocturnal Lagophthalmos, aiding in the prevention of corneal defects or damage. It is also suitable for daytime use as an eyelid closure therapy, stabilizing the eyelid in the closed portion, retaining moisture and encouraging the body to naturally heal the cornea. For this application you would wear one patch for day use, changing for the night for the needed durations. To heal surface defects the Tarsus Patch may need to be worn for a week, or even a month changing every morning and night or as needed. More comfort, effectiveness, and less irritability, make the Tarsus Eyelid Patch ideal for pediatric use, worn under an eye shield in some cases to prevent removal. Eyelid closure or occlusion are the method to address pediatric Amblyopia or lazy eye. In young children and adolescents, it should be treated using part-time occlusion of the fellow eye and the underlying cause should be addressed.
It is applied to the upper eyelid above the eye-opening, and easily aligned and properly placed with the aid of a light blue arching line on the patch. It's design or shape, does not intrude on the eyelashes or the corners of the eyes, making it much more comfortable than other products that crush the eyelashes under them and stick the eyelids together. This is very irritating, and in some cases doesn't give a complete eyelid closure which can, in the case of sedated surgeries, even damage the cornea, in some cases causing corneal blindness. When the Tarsus Patch is applied to the closed upper eyelid, the adhesion conforms the patch to the curvatures of the eyeball, on the eyelid, and the under brow, it acquires form and structure, holding the eyelid in the closed position in resistance to the retraction of the levator muscle.

 

Our device and method make it possible, with one finger, to lower and open the bottom eyelid enabling a caregiver or the wearer to add medicine or artificial tears. Upon the release of the lower eyelid, the eye is closed again as the upper eyelid is held in the closed position by the applied Tarsus Patch. This gives our product the ability to accompany eye medicines, as well as for use after eye surgeries to enhance healing. There have been studies that show that eyelid closure enhances the delivery, and effectiveness of some eye medicines. It is also excellent for use during sedated surgeries and on paralyzed patients for eye closure, and has possible uses by NASA astronauts in space.

Our product is specifically designed for the essence of eyelid closure by a patient, with the wearers comfort in mind. We have put serious thought into solving the neglected problem of comfortable effective eye closure. With forward thinking design, innovation, and the latest technologies and materials, we have created a product that antiquates our competition.

 

In some cases partial eyelid closure is desired. This can be achieved with the Tarsus Patch by positioning at application. Application positioning is key in all cases. The wearer needs to find the application positioning or sweet spot for their individual orbital eye socket anatomy and the desired amount of eyelid closure desired.

Due to lower lid anatomy or various lower lid functionality issues it may be necessary to support the lower lid to achieve effective eyelid closure.

 

USPTO Patent numbers: 10076448, and 10,799,395

Product code: HOY

FDA Class 1,  510(K) Exempt.

Classification name: Shield, eye, ophthalmic. Eye patch, non-sterile. Sterile Surgical Adhesive Eye Patch,

Regulation numbers: 878.4440, 886.4750, 81751822161, 81751822147, 81751822123

Specialty code: OP - Ophthalmic

NICTAVI LLC, DBA - Nictavi, FDA CDRH Registration and Listing. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

FDA Registration Number: 3017733452

FDA Owner Operator Number: 10079434

 

NPPES National Provider Identifier Taxonomies

NPI #1104411701 Sole Proprietor

Taxonomy: Level II - Classification level code 332B00000X

License: 0002029859-0001-1

State: CA

Details: Durable Medical Equipment & Medical Supplies

 

California Sellers Permit Account Number: 246567744 - 00001

Los Angeles Tax Registration Account Number: 0002029859-0001-1

EIN / TIN: 85 - 3543491

 

Certifications and Registrations: 

  1. State of California Small Business Certification ID 2028555 (SB micro)

  2. County Local Small Business Enterprise (LSBE)- 092569

  3. County Community Business Enterprise Program (CBE) - 092570 

  4. LA RAMP as Nictavi LLC DBA Nictavi ID 203120

  5. LA County Vendor Number: 206417

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Codes

NAICS

423460 - Ophthalmic Goods Merchant Wholesalers, Ophthalmic Goods (except cameras) Merchant Wholesalers, Optometric Equipment and Supplies Merchant Wholesalers

339115 - Ophthalmic Goods Manufacturing

423450 – Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

SIC:

5048 - Ophthalmic Goods 

5995 - Optical Goods Stores

5047 - Medical and Hospital Equipment

CMS assigned HCPCS code: A6412 - Eye patch, occlusive, each.