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Important information

• Advertising Review:

  BBB sent correspondence to Renovatio Aesthetics and Wellness on July 5, July 12, July 26, and August 9, 2023, requesting licensing information and substantiation for medical claims on the website https://renovatiowellnessgroup.com/. To date, the business has not responded to our request. The information that BBB has provided is accurate to the best of BBB's knowledge upon publication.

  BBB has found information with regard to Ketamine being a controlled substance, requiring a DEA license. BBB requested a copy of the business DEA license.

  BBB asked if the business has a written practice agreement with a collaborating physician or with a New York State Health Department licensed health care facility.
  
  The business has a NYS Office of Professions owner or employee licensed as a Nurse Practitioner in Acute Care. BBB asked if acute care licensed individuals can treat illnesses that develop suddenly and last a short period of time? BBB asked if the Nurse Practitioner is licensed for any other types of care?
  
  BBB asked if this licensure allows the owner/employee to prescribe/provide ketamine infusion therapy for psychological, psychiatric, and chronic pain.
  
  All advertisers should be able to substantiate all advertised claims and be able to provide that substantiation upon request.
  
  BBB Code of Advertising #34 Claimed Results states:
  
  Claims relating to performance, energy savings, safety, efficacy or results for a product or service should be based on recent and competent testing or other objective data.
  
  https://renovatiowellnessgroup.com/services/ketamine-treatment/
  
  The use of Ketamine for depression has been named “the biggest discovery in mental health in decades.”
  
  BBB requested substantiation for this claim.
  
  The images, “A picture of a neuron.” on the website, imply that ketamine will restore connections in the brain.
  
  The image source that BBB has found is from a study done at Yale University using rats, which is not stated in your advertising. While It may be possible that ketamine can achieve this in human brains, the information/photo provided is from a study on rats. The image source should be cited as well as provide information that the study was done on rats. This information does not prove that this will happen with neural growth in the human brain and should be stated.
  
  The images titled “A CT scan of the human brain” on the website imply that after ketamine treatments, the brain will appear as the non-depressed brain that is pictured.
  
  The image source for this photo that BBB has found is from the mayo clinic from a PET scan for a depressed vs. non-depressed brain, with no mention that it is a scan of the same brain, and no mention of ketamine treatments, or any treatments. (https://www.mayoclinic.org/tests-procedures/pet-scan/multimedia/-pet-scan-of-the-brain-for-depression/img-20007400) The image source is not cited and the information provided, or not provided, may be misleading.
  
  The business also states in this paragraph, “The drug has been approved by the U.S. Department of Veterans Affairs for treatment of military veterans suffering from symptoms of PTSD. “ which provides a link to another business that provides Ketamine Infusion Therapies in Virginia at https://virginiainfusiontherapies.com/va-guidelines-approve-ketamine-for-veterans/.  This does not substantiate the claim that The US Department of Veteran Affairs has approved this treatment.
  
  BBB requested that the business substantiate the claim that the U.S. Department of Veterans Affairs has approved this treatment for PTSD as BBB has been unable to verify this claim. BBB has found the following document from the VA titled, ‘Ketamine Infusion for Treatment Resistant Depression and Severe Suicidal Ideation National Protocol Guidance’ https://www.mirecc.va.gov/visn19/cpg/recs/10/resources/Ketamin-Infusion-for-Treatment-Resistant-Depression_Rev-Feb-2022_508.pdf. This document also states the following, “• A VA psychiatrist or a VA licensed health-care provider (i.e., CPP, NP, PA) has evaluated the patient and determined and documented that the patient qualifies for ketamine treatment in patient’s medical record.”
  
  The information that BBB has found is located here https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified and states that to date, only a nasal spray has been approved by the FDA and is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).
  
  https://renovatiowellnessgroup.com/services/migraine-treatment-utica/
  
  “There have been several recent reports in the media profiling the type of patient successes that we here at Thrive Wellness Groups have seen regularly. Less well known is Ketamine’s effectiveness in treating several pain syndromes, including migraine headaches.”
  
  BBB asked that the business provide copies of the recent reports in the media that they are referring to.
  
  BBB asked Who is Thrive Wellness Group and how their business is related to them?
  
  BBB requested substantiation for the claim that iv infused Ketamine is effective in treating pain syndromes and migraine headaches with conclusive evidence from human clinical trials. The only information that BBB had found is from October of 2021 here, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520840/ and the conclusion states. “Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.” BBB welcomed any updated results or information to support the claims the business made.
  
  BBB requested a link to Eric Schwenk’s study and asked that it be added to the website to substantiate the claimed results the website is citing.
  
  BBB asked that the business substantiate the claim in the video on the page that ketamine promotes healing within those cells to provide long term relief.
  
  https://renovatiowellnessgroup.com/services/depression-treatment-utica/#
  
  BBB requested that the business provide conclusive evidence from human clinical studies for IV infused ketamine use for each of the depressive disorders that the website mentions:
  
  "Some of the typical diagnoses of depressive disorders may include:
  
  Major Depressive Disorder (MDD): Also known as Clinical Depression or Unipolar Depression. The most common form of depression. It can be just a single episode, but some people may experience it periodically throughout their lives.
  Postpartum Depression: A type of depression usually brought on by the hormonal shifts women experience the months or year following childbirth.
  Seasonal Affective Disorder (SAD):  Depression caused by a change in the circadian rhythm of the body, usually bringing on depression during a specific season of the year.
  Situational Depression: While the symptoms are much like Major Depressive Disorder, this is depression brought on by a specific event, such as the death of a loved one or a life-threatening event.
  Persistent Depression: Also known as dysthymia or chronic depression, this is depression that lasts for two years or more.
  Manic Depression/Bipolar Disorder: Characterized by periods of mania alternating with periods of intense depression."

  https://renovatiowellnessgroup.com/services/ptsd-treatment-utica/
  
  The video on this page is of a veteran discussing ketamine treatments for PTSD. BBB asked if the business actually offers ketamine infusion treatments for PTSD? The couple’s package on the page being described does not mention ketamine treatments.
  
  BBB requested that if the business is providing ketamine treatments for PTSD, to provide conclusive evidence from human clinical trials supporting the use of IV infused ketamine for PTSD, as BBB has been unable to verify this treatment for PTSD is approved by the Veterans Administration.
  
  BBB requested that the business provide substantiation for the awards that have been won as stated in their advertising, “Our award winning treatments are combined in this package to offer you the perfect couple.”
  
  https://renovatiowellnessgroup.com/services/anxiety-treatment-utica/
  
  BBB requested that the business provide conclusive evidence from human clinical trials supporting the use of IV infused ketamine for all of the anxiety disorders featured on the page as follows:
  
  "Ketamine for Anxiety
  
  Ketamine, first developed and approved by the FDA as an anesthetic, is a promising new innovation in the field of anxiety treatment. While you may know it as the club drug often abused as Special K, Ketamine is what some doctors are calling the biggest breakthrough in depression and anxiety treatment in decades. When infused at a low dose into the bloodstream, research shows that Ketamine may be up to 80% effective at providing relief for anxiety disorder symptoms.
  
  The Different Types of Anxiety Disorders
  
  Anxiety tends to vary between each individual case, but there are a few basic types of anxiety disorders most cases can be identified as:
  
  Generalized Anxiety Disorder (GAD): Characterized by consistent worry, anxiety, and tension, even if there is nothing to bring it on.
  Obsessive-Compulsive Disorder (OCD): Characterized by recurrent intrusive thoughts (known as obsessions) and repetitive behaviors (known as compulsions). These compulsions, sometimes called rituals, are performed in an attempt to prevent these obsessive thoughts or make them subside. The compulsions typically only offer temporary relief, however, and can further contribute to anxiety.
  Panic Disorder: Characterized by repeated episodes of intense fear that bring on physical symptoms such as chest pain, shortness of breath, heart palpitations, dizziness, or abdominal distress.
  Post-Traumatic Stress Disorder (PTSD): Brought on after experiencing or witnessing a life-threatening or traumatic event.
  Social Anxiety Disorder (Social Phobia): Characterized by intense anxiety and self-consciousness in everyday social situations. It may be limited to only public speaking, but some people may experience symptoms whenever they are around other people.
  Agoraphobia: Characterized by avoidance of places or situations that trigger feelings of anxiety or panic."
  
  https://renovatiowellnessgroup.com/services/chronic-pain-treatment-utica/ - This link appears under the tab for ketamine services, yet makes no mention of ketamine treatments. It only references manicures and pedicures for chronic pain treatment. The video on the page only states to learn more about ketamine. BBB requested evidence of human clinical trials supporting the use of IV ketamine therapy for chronic pain.
  
  https://renovatiowellnessgroup.com/services/ocd-treatment-rapid-utica/ - This link appears under the tab for ketamine services, yet makes no reference to ketamine treatments. It only references types of massage therapy for OCD treatment. BBB requested evidence of human clinical trials supporting the use of IV ketamine therapy for OCD treatment.
  
  The business offers IV hydration therapy and vitamin therapy. BBB asked the following questions regarding these services.
  
  Are the products properly labeled with adequate directions for use?
  
  Are the IV cocktails compounded in the businesses facility? Is the business a licensed pharmacy or facility with a certified ISO-5 classified area for sterile compounding and registered as a 503B?
  
  BBB asked that the business provide the name and New York state licensing information for the pharmacist and/or physician that the IV cocktails are compounded by.
  
  BBB asked for the name of the outsourcing facility that compounds the iv's (if used), and proof of registration with the FDA.
  
  BBB asked for the name and licensing information for the physician that prescribes the patient specific IV cocktails.
  
  BBB requested more information regarding the medicinal and therapeutic claims/statements, and any supporting evidence to support the claims.
  
  https://renovatiowellnessgroup.com/iv-therapy/
  
  BBB requested that the business substantiate the following claims:
  
  “IV vitamin therapy provides direct absorption of vitamins and minerals, which are utilized more effectively than when taking vitamins by mouth.”
  
  “IV vitamin therapy can also help decrease inflammation, encourage healing, and support mental processes.”
  
  "Rehydrate your body and combat fatigue from dehydration"
  
  "Burn fat, feel energized and boost Your metabolism"
  
  "Decrease recovery time & enhance your performance"
  
  "Strengthen your immune system and feel better faster"
  
  "Minimize bloating, irritability, abdominal and lower back pain"
  
  "Fight acne, wrinkles and tired skin from the inside out"
  
  High Dose Vitamin C IV
  
  "Prevents sickness, boosting the immune system, and recovering from illness"
  
  "Reduce seasonal allergies, fatigue and restore natural balance"
  
  "Hangover Cure IV
  
  Dehydration fix, anti-nausea, and headache medicine. Hangovers can be cured in minutes"
  
  "NAD and NAD+
  
  NICOTINAMIDE ADENINE DINUCLEO
  Improve mental clarity, alertness, concentration, and memory"