EnduraKT: Pain Relief for Enhanced Recovery – Non-Opioid, Safe, Effective.

Ventis Pharma Corporation strives to become a world leader in advancing pain management solutions. Our innovative, long-acting, low-toxicity Formulations are designed to reduce surgical pain and treat chronic pain conditions safely and effectively. By making our Formulations cost-effective and available throughout the world, we can improve the quality of life for all patients.

Ventis Pharma has achieved this by developing Endura-KT, a safe, long-lasting, low-toxicity, patented anesthesia Formulations. Endura-Kit is cost-efficient and may provide an effective alternative to opioids.

As the developer of certain patented formulations, Ventis Pharma has provided Nubratori RX the license to manufacture the Endura-KT formulation under its FDA 503B Outsourcing facility. Nubratori RX is a licensed FDA 503B Outsourcing Facility where all products are manufactured in the USA according to FDA CGMP regulations. Nubratori RX website is : https://www.nubratorirx.com

(Tetracaine 0.2%, Lidocaine 0.4%, Epinephrine 1:1000)

• EnduraKT is a non-opioid anesthetic injection designed for extended post-surgical pain relief. Unlike most options that use bupivacaine, EnduraKT is based on tetracaine and epinephrine, allowing faster onset (11 minutes) and up to 72 hours of pain relief with fewer toxicity concerns. Competing products can take up to 30 minutes to take effect.

• EnduraKT aligns well with Enhanced Recovery After Surgery (ERAS) protocols by supporting faster patient recovery, non-opioid pain management, and extended relief, all contributing to improved patient satisfaction and outcomes.

• Endura-KT contains two components, which, when combined, mixes into a preservative-free patented local anesthetic compound.

• Endura-KT consists of one preloaded Luer-Lock syringe with an 18g mixing needle containing 0.2ml of Epinephrine 1:1000, and one vial containing 50ml of Tetracaine and Lidocaine. Combining these two components results in a solution of 0.2% Tetracaine and 0.4% Lidocaine with Epinephrine 1:250,000.

• The maximum recommended dose is 1.5ml/kg IBW. (1)

Yes, EnduraKT is safe for pediatric use. Its tetracaine-based formula offers a low toxicity profile, making it suitable for various age groups, including children, without the risks associated with bupivacaine.

Endura-KT is a novel compound that is safe, and effective and provides opioid-free pain relief for patients after surgery.

The two-part injectable contains the following components:

TETRACAINE is an amino-ester class local anesthetic. Clinicians have used it for a variety of purposes in the US since the early 1930s. A 0.2% concentration of Tetracaine is not neurotoxic and produces minimal motor blockade. This allows longer and more complete sensory blockade, which is ideal for post-operative analgesia. Tetracaine is immediately metabolized in contact with blood, ameliorating risks associated with unintentional intravascular injection. This means the substance carries minimal risk. (3)

LIDOCAINE is an amino-amide that was approved as a local anesthetic in the U.S. in 1948. It has a long record of safety and efficacy and is administered millions of times each year in the U.S. It is often administered in formulations combined with Epinephrine. It is both common and effective to combine local anesthetic with different onset times and durations to achieve better performance for patients. (2,8,9)

EPINEPHRINE at the 1;250,000 level, has greater direct alpha-2 effect than traditionally understood vasoconstrictive effects, with similar pharmacodynamics in terms of K+ channel gating effects and trans-compartmental movement of local anesthetic within the neuron. All of this contributes to the observed extended duration of sensory blockade by the combination product.

There is a strong demand for non-opioid pain control after surgery. Endura-KT may provide an effective solution for this by offering patients a safe and effective option for pain relief. (4,5)

The primary goal for adequate pain relief after surgery is to increase the patient’s level of comfort with the least possible side effects. This approach allows for the completion of important tasks such as early ambulation and range of motion. Proper pain relief subsequently results in decreased postoperative complications. (6,7)

The benefits of receiving opioid-free pain relief may lead to patients experiencing little to no risk of developing opioid tolerance or addiction, as well as avoiding any opioid-related side effects. Minimizing opioid use, particularly in the setting of an enhanced recovery after surgery protocol, has been shown to decrease hospital length of stay after numerous procedures. (5,7)

*Endura-Kit is not recommended for topical use or for spinal anesthesia. This product is an off-label use of three long-available and extremely safe anesthetics.

Medications may only be ordered by healthcare providers when it is determined that the product is clinically significant over other commercially available products.

https://www.endurakit.com

info@ventispharma.com

http://www.ventispharma.com

1. Local Anesthetics. Ian K McLeod, MD; Chief Editor: Arlen D Meyers, MD, MBA et al. Updated: Mar 18, 2015. http://emedicine.medscape.com/article/873879-overview#a5.

2. Epinephrine prolongs duration of subcutaneous infiltration of local anesthesia in a dose- related manner. Correlation with magnitude of vasoconstriction. S Liu , R L Carpenter , A A Chiu, T J McGill, S A Mantell. Regional Anesth. Sep-Oct 1995;20(5):378-84.

3. Laparoscopic-Guided Transversus Abdominis Plane Block for Colorectal Surgery, Joanne Favuzza, D.O. • Conor P. Delaney, M.D. Dis Colon Rectum 2013; 56: 389–391DOI: 10.1097/DCR.0b013e318280549b © The ASCRS 2013.

4. The Opioid Epidemic: By the Numbers. http://www.hhs.gov/opioids/

5. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. Chad M. Brummett, MD, et al. JAMA Surg. Published online April 12, 2017. doi:10.1001/jamasurg.2017.0504.

6. Benefit and risks of local anesthetics in infants and children. Gunter JB. Paediatric Drugs. 2002;4(10):649-72.

7. Evidence-based practice supports adopting ERAS protocols. OR Manager Vol. 33 No. 5 May 2017. Brydges G.

8. On the Mechanism by Which Epinephrine Potentiates Lidocaine's Peripheral Nerve Block Catherine J. Sinnott, B.A. ; Lawrence P. Cogswell, Ph.D. ; Anthony Johnson, B.S. ; Gary R. Strichartz, Ph.D. Anesthesiology January 2003, Vol. 98, 181–188. https://doi.org/10.1097/00000542-200301000-00028 .

9. Anesthesiology. 1981 Mar;54(3):177-81. Mixtures of local anesthetics are no more toxic than the parent drugs. de Jong RH, Bonin JD.

FDA Disclaimer:

This product has not been evaluated or approved by the FDA.

*Nubratori RX Products are produced and lawfully sold in the USA, under the FDA Structured Product Listing Marketing Category #Cl81659 "Outsourcing Facility Compounded Human Drug Product" (Exempt from Approval Requirements)

*Under the Drug Quality and Security Act of 2013 enacted by Congress human drug products compounded by an outsourcing facility, such as Nubratori RX, are exempt from the following three sections of the FD&C Act:

As the developers and patent holders of the Endura-KT formulation, please call us if you have any questions regarding any usage, storage, procedural, contraindications, medical or adverse reactions at 1-800-441-5841. We will be happy to setup a peer to peer discussion to be sure that any anesthesiologist, surgeons, CRNA or any other healthcare professional has all the safety information they need on Endura-KT

Endura-KT's formulation is specifically designed to provide effective pain relief without the use of opioids, thus minimizing the risks of opioid-related side effects, tolerance, and addiction.