Home Blog Page 31

FDA Seeks Comments on Cryoablation

0

After eight years of trials, successes and numerous women happy they no longer have breast cancer, the FDA is holding a meeting next month and inviting comments on the ProSense Cryoablation System, the non-invasive, non-drug cure for some types of breast cancer.

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee gave notice of its scheduled public advisory meeting in Maryland on Thursday, November 7 and requested comments to be heard that day if submitted no later than this Thursday., October 17.

As a thrilled and cured breast cancer survivor thanks to this cryoablation procedure created by Ice Cure, a company in Caesarea, Israel, eight years ago, I am on the schedule to present testimony during that meeting on the success of the cryoablation performed by Dr. Kenneth Tomkovich, a radiologist at Centra State Hospital in Freehold, at the very onset of the trial period eight years ago.

Purpose of the meeting is for the Committee to discuss, make recommendations, and vote on clinical information related to the request for the ProSense Cryoablation System sponsored by Ice Cure Medical Ltd. The discussion will focus on the sponsor’s proposed indication: “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.”

Persons who have had this treatment, want it to be approved so insurance and hospitals will include it, have relatives or friends who have been part of the success rate of this hour long procedure performed without need of either anesthesia or drugs are also invited to send comments to the FDA for consideration during the hearing.

FDA established a docket for public comment at this meeting. For access to sending in comments go to https://www.regulations.gov/document/FDA-2024-N-4057-0001 and click on comment.

Comments received on or before October 17 will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. Comments will also be accepted until 11:59 p.m. eastern time at the end of December 9, and all comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Obviously, these comments will not be addressed during the November session.

The Food and Drug Administration (FDA) in announcing the advisory committee meeting, indicated its general function is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. The meeting is being held at the Holiday inn, Two Montgomery Village Ave., Gaithersburg, Maryland and will begin at 9 a.m., ending at 6 p.m.

Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

Persons wishing to submit comments electronically, including attachments, can access  HERE. Comments will be posted to the docket unchanged. Because comments will be made public, writers are solely responsible for ensuring their comment does not include any confidential information the writer does not wish to be posted, such as medical information, anyone’s Social Security number, or confidential business information. Persons wishing to submit comments

If you want to submit a comment with confidential information they do not wish to be made available to the public, should submit the comment as a written/paper submission to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For access to the docket to read background documents or the electronic and written/paper comments received, visit HERE and insert the docket number, FDA-2024-N-4057 into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Please see below on stories that I have written about my own journey with Breast Cancer, and my amazing success with IceCure Cryoblation

From Body Massage to Mammography

And now it’s official!

The end of a Breast Cancer Procedure trial

A Company, A Cure, A Friend. Pray for Israel

Beat the Big “C”

The Diagnosis & a Drawing of my Breast

Breast Cancer: My Only Pain is Guilt

 

Ice Cure & Dr. Tomkovich

 

 

It Worked for Me!

I had breast cancer for 47 days: my journey with breast cryoablation

https://www.facebook.com/IceCureMedical/videos/470493228813181
Cryoablation

Port Monmouth Fire Company Helps

0
Port Monmouth Fire Company
So many Bayshore residents want to help residents of North Carolina,, Georgia and Florida. in the wake of Hurricane Helen and now Hurricane Milton.  Highlands has adopted a family and the borough is working with volunteers on the ground in Lake Lure, North Carolina to get food and other necessities to them.
Tomorrow, Sunday Oct. 13,.  The Port Monmouth Fire Company is also inviting resident to drop off non-perishable items and other needed products for delivery to  North Carolina. The Port Monmouth volunteers are working with Whirl Construction who will deliver the truck load to the South.  Items will be collected Sunday, October 13 between 10 a.m. and 3 p.m. at the Port Monmouth Fire Company, 125 Main St., Port Monmouth
Port Monmouth Fire Company

M. Claire French Award for Leadership

0
Middletown Mayor Tony Perry

Middletown Mayor Tony Perry is the winner of the 2024 M. Claire French Award for Leadership in Historic Preservation, Monmouth County Clerk Christine Giordano Hanlon announced this week. He will be honored and presented with the award at the 29th Annual Archives and History Day Saturday, October 26 at the Robert J. Collins Arena at Brookdale Community College.

Monmouth County Clerk Christine Giordano Hanlon

Tony Perry has been an unwavering champion in the preservation of Middletown’s rich historical legacy and has demonstrated a profound impact on historic preservation in our County,” said Hanlon. “His work has helped ensure a vital part of Monmouth County history will be honored and appreciated for generations to come.”

As Mayor since 2019 and a member of the Middletown Township Committee since 2017, Perry has played an instrumental role in improving historical sites, maintaining open space and participating in historical initiatives.

The mayor spearheaded the creation of Middletown’s America 250 Committee to develop programs and events coinciding with the nation’s historic Sesquicentennial celebration. He also serves on the Board of the Crossroads of the American Revolution National Heritage Area established to promote a greater understanding of a Revolutionary era historical sites.

In addition, Mayor Perry has championed critical preservation projects including the restoration of the historic Joseph Murray Farmhouse, a vital link to Middletown’s agricultural heritage. His leadership helped ensure the landmark continued to stand as a tangible connection to the town’s past.

Perry has also been a leader of preserving Middletown’s maritime history, exemplified by the current restoration of the historic Conover Beacon in Leonardo, an iconic symbol of Middletown’s maritime traditions. He also worked with the Township Committee to pass a resolution that took into consideration historic and aesthetic significance when developing a plan for the necessary replacement of the Oceanic Bridge over the Navesink River.

Perry championed an awareness campaign focusing on educating residents about the importance of open space and landmark preservation, an effort that resulted in voters approving a referendum to establish a trust to preserve undeveloped land and rehabilitate and restore historic sites.

M.Claire French

The M. Claire French Award for Leadership in Historic Preservation recognizes outstanding achievements of an elected official, government employee, public servant or civic organization in supporting historic preservation in Monmouth County through education, development, planning, rehabilitation, advocacy, community leadership or other means. Created in 2015, the award is named after M. Claire French, Hanlon’s predecessor, who served as County Clerk for 18 years until her retirement in 2015.

The County Clerk’s 2024 Archives and History Day on October 26, runs from 9 a.m. to 1:30 p.m. with the awards presentations beginning at 12:30 p.m. This year’s Archives exhibit, a photography exhibit which will be on display at Archives and History Day, is titled “Monmouth County Life Through a Lens: Photographs from the Evans Studio, 1943-1987.”

For more information about Archives and History Day, visit MonmouthCountyClerk.com/Archives or contact the Monmouth County Archives at 732-308-3771, ext. 3772.

Leadership Leadership Leadership

Waterwitch Neighborhood Grocer and Gourmet

0

Mayor and Council together with the Business Partnership will host a ribbon cutting ceremony at Waterwitch Neighborhood Grocer and Gourmet on Friday, October 25 at 6:00 pm.

The new Grocery and gourmet shop which opened last month is owned by Nancy Burton and Eileen Ricco, popular and successful owners of Garden Flowers & Plants, located next to the Grocer.

The business professional expanded their business to include a larger shopping experience for Bayshore residents and beyond. Both shops are located on Waterwitch Ave. at Shore Drive, across from Huddy Park.

After purchasing the adjacent commercial space three years ago, the women transformed it into a unique shopping experience to complement the garden shop they opened in 2013.

The Grocery and Gourmet shop offers curated conventional and organic produce, dairy, cheeses, gluten-free, and plant-based items as well as fresh bread and pastries, specialty coffees and cold brews from local roasters. There is a Pachamama Juice Bar offering cold-pressed juices, bowls, smoothies, and salads.

Customized gourmet gift baskets with local delivery are also offered.

Supporting local businesses and the economy, Waterwitch Neighborhood Grocer & Gourmet sources products from nearby farms and artisans. The store is open Monday through– Saturday, from 7 am to 9 pm; and Sundays, from 7 am to 5 pm

The public is invited to join the celebration and experience the ultimate neighborhood grocery store!

 Waterwitch

Family Day on the Farm

0
Family Day

Families are invited to spend an afternoon this Sunday visiting a Middletown farm and enjoying refreshments, games, crafts and an opportunity to meet and greet horses, donkeys and other animals who live happily on Quasar Farms after being rescued from various situations and locations in past years.

Danielle Tomassetti, a former criminal and family attorney who gave up that profession in order to care for animals she rescues, provides sanctuary for a variety of farm animals at Buddha Barn, her abused animal sanctuary on Quasar Farm. The farm is located at 680 Kings Highway East with entrance off Sarah Lane.

Sunday’s event, a Family Day on the Farm, will help raise funds to support the care of the animals and at the same time enable residents to see the care and attention they are given.

Guests are invited to attend the Family Farm Day between 11 a.m. and 1 p.m. with tickets $15 for adults, and $12 for children at the door.

In addition to meeting the animals, another featured event of the Family Farm Day will be cowboy hat decorating. Guests are invited to bring their own cowboy hats or purchase one at the Farm.

Tomassetti, her husband and their twin sons also maintain a horse boarding business on the farm, but her desire to help injured and abused animals came after her own dog died in a fire that also destroyed the family’s home. She named Buddha Barn in honor of her dog and feels the therapy she offers abused animals helps her through the loss of her own pet.

A native of New Jersey, Daniella, has lived in several other towns in Monmouth County, but the family fell in love with the Middletown and Bayshore area, both because of the friendliness of the residents and neighbors and its proximity to the ocean and bay.

Tomasetti is a member of the Atlantic Highlands Chamber of Commerce.

 

Family  Day Family Day Family Day

Billy Ptak Funeral Mass

0
Funeral

The funeral mass for William J. Ptak (Billy) will be held Saturday at 9 a.m. at Our Lady of Perpetual Help Church, Route 36, Highlands.

Ptak, of Jacksonville, Fla, is a native of Highlands, son of Ben and Geraldine Ptak. He died August. 30 after a brief illness.

A veteran of ten years in the US Navy, Bill was also life guard at Gateway National Recreation Area at Sandy Hook for many years.

Bill was a member of the Basilica of the Immaculate Conception Catholic Church in Jacksonville and a communicant of Our Lady of Perpetual Help Catholic Church while living here.

Funeral

Fall Taste of Highlands

0
taste

The fifth annual Fall Taste of Highlands sponsored by the Highlands Business Partnership (HBP) will be held this Saturday, Oct. 12 from Noon to 5:00 PM.

The event will take place rain or shine. Tickets can be purchased online for $45.00 per person.

The ticket price includes a Fall Taste of Highlands map of participating businesses, free parking, and access to the Seastreak Courtesy Shuttle, which will take you to and from each stop on the map. Tickets can also be purchased at Huddy Park on the day of the event from 11AM to 1 PM.

Fall Taste of Highlands will feature an autumn theme, where food lovers will enjoy five hours of samples of diverse cuisine and cocktails from seventeen establishments throughout the town.

Participating businesses include Bahrs Landing Restaurant, Bridge Marina, Chilangos Authentic Mexican, Chubby Pickle, Farmacie by the French Market, Feed & Seed, Franny’s Pizzeria & Restaurant, Fresh, Hinlickity’s Ice Cream Parlor, Moby’s, Off the Hook, Proving Ground, Saltwater Social, Sandbox at Seastreak Beach, Seafarer Bar, Spiritual Beauty & Waterwitch Neighborhood Grocer and Gourmet.

Ticket holders should check in at Huddy Park on Bay & Waterwitch Avenues and pick up their map. A host at each establishment will stamp your map. Those who visit ALL stops will be eligible to win a prize by returning their fully stamped map to your last stop on the map.

The Highlands Business Partnership is a 501(c)(3) non-profit organization. Programs and events are made possible by sponsors including, Monmouth County Tourism, Montecalvo/Bayshore Family of Companies, Bahrs Landing, Farmacie by the French Market, Feed & Seed, Dovetail Vintage Rentals, Hufnagel Tree Service, In the Garden, Off the Hook, Proving Ground, Seafarer, Sandbox at Seastreak, Valley Bank and WRAT, 95.9.

For more information on Fall Taste of Highlands, email the Highlands Business Partnership at hbpadmin@highlandsnj.com or call 732-291-4713.

 Taste Taste

Highlands Helps Hurricane Victims

0
Highlands

Highlands, knowing from personal experience the immediate needs and utter devastation of families in the wake of horrific hurricanes, is pooling efforts and calling on volunteers and donors to bring disaster relief to Lake Lure, North Carolina, and the family of ten the borough is adopting to ensure immediate assistance.

Valerie and Frank Montecalvo

First to step up to the plate with huge enthusiasm and financial assistance is the Montecalvo Family Foundation. That generous family is matching all monetary donations for this first wave of relief up to $50,000 through their Foundation so every dollar collected during this first wave of assistance will go to those who are homeless and seeking refuge from the upcoming colder temperatures.

Highlands Police Chief Rob Burton

Highlands Police Chief Rob Burton has two trailers ready to haul to Lake Lure, once they’re filled and here is where everyone can do something as well. Tammy Tappan, a volunteer in Lake Lure has provided a list of what is needed most.

The Lake Lure police have been in contact with Chief Burton and are allowing them to drive the trailers with donations and supplies to help their residents even when town access is still only permitted for residents. Gift Cards can be dropped off at the Highlands Police Department. Financial contributions designated to the Lake Lure Community to help provide emergency supplies, rebuild homes and critical support to families can be made directly to: https://givebutter.com/westernnc or text NCSTRONG to 53555.

The borough has adopted the Kitchen family from Tryon, North Carolina, parents and eight children ranging in age from 1 to 15 who have been displaced. The borough has direct contact with a local non-profit, Força Foundation in helping this family find a temporary home. –

Rosemary Ryan

All these coordinated efforts are being led by the Highlands Volunteer First Aid, Fire Departments, Highlands Police Department and OEM and Rosemary Ryan of the First Aid and Hope for Highlands President who is putting her experience and organization skills to work getting donations and aid. Rosemary said, “I’ve been in contact with Tammy Tappan, the boots-on-the-ground volunteer in Lake Lure, who is assisting with the relief efforts. Many families are currently in shelters or makeshift accommodations, they need our help.” Some of the most critical needs, she said, are for blankets, sweatshirts, toiletries, personal hygiene products, diapers, cleaning supplies, bottled water, non-perishable food, diapers, baby formula, flashlights, batteries and battery packs.

Highlands Mayor Carolyn Broullon

In inviting everyone in the borough to help neighbors in North Carolina facing so much loss, Mayor Carolyn Broullon said “as survivors ourselves, remember how Highlands was devastated by Super Storm Sandy–12 years ago, we know what these communities are enduring. Remember our gratitude when others stepped up to help? Please join us wrapping our arms around Lake Lure, North Carolina. “We’ve been in their shoes; we know what it’s like to lose everything so let’s pull together and help those hurting.”

Valerie Montecalvo of her Family Foundation, in inviting everyone to participate in the borough’s aid, said, “These are very resilient folks; but their loss is tremendous—we are all in this together and we can provide life-saving assistance to those who need it most.”

Donations of supplies can be dropped off at Highlands Borough Police Department now until October 15. For questions or a need to pick up donation, contact Rosemary Ryan at the Highlands First Aid (732) 778-9267 or Cynthia Fair at the Montecalvo Family of Companies (732) 738-6000 ext. 214. For further information on the Montecalvo Family Foundation contact Cynthia Fair at cynthiaf@bayshorerecycling.com

Highlands

Rebecca Wells Wants To Keep Her Seat

0
Rebecca Wells

She inherited not only a love for her community but also that strong feeling she has that she needs to give back in every way she can. These are the reasons Rebecca Wells says are drawing her to seek another term on the school board, this time the Henry Hudson Regional Board of Education.

A native of Highlands, Rebecca Kane Wells, like her father and brother, was a chief of the Highlands Fire Department and continues to actively serve as captain of the department. She has served the volunteer department for a quarter of a century and was its first female fire chief when she held that office in 2009. Her husband, Charles, who is the borough’s fire marshal, is also a former chief of the department.

The active ever busy professional also served 15 years on the borough council, including as council president and has been a member of the Highlands Housing Authority since 2010. That the town appreciates everything the former councilwoman has done for the borough was evidenced in 2013 when she was selected as Grand Marshall of the Highlands St. Patricks’ Day Parade.

In education, Becky served on three boards of education; she was a member of the Henry Hudson board for one term, the Highlands Board of Education until it was closed last year and now on the current board.

That is the transitional board that was appointed and will be active until January, when the five persons from Highlands and four from Atlantic Highlands who are elected in November will take office as the first elected board of the new Prek-12 Henry Hudson Regional School Board of Education. She is also a member of the Tri-District Education Foundation.

The board member feels these elected and appointed positions, her own personal experience history and continuing to stay active and allow her to see through initiatives happening in the school district will make her an effective board member. The fact the three local schools regionalized into one district this year “was a great accomplishment, decades in the making,” and she was happy to be a part of the transition.

However, she said, she feels all the work and time involved in making the progress “took many hours of administration from our true task at hand, the children and their educational goals.”

A graduate of Henry Hudson, Rebecca also graduated four years later from the Middletown Township Fire Academy, and in 2008 received a degree in business administration from New Jersey City University. She is a contract manager with York Telecom Corporation in Wall where she has been employed for 18 years.

Addressing the question of regionalization with Sea Bright in the school district, Rebecca said as a taxpayer in Highlands she would love the addition for the benefits it would bring. However, she added, “they need to be able to get out of their current arrangement with Oceanport to join us. To that end once they are allowed to be able to join another district, we have to make sure that it is financially prudent for both communities.”

The candidate said while she is aware that under current financial formula proposed should Sea Bright become part of the district “there is no way financially that Highlands can lose.” But she added we have to be mindful that for this to successfully pass it must pass in both communities” of Highlands and Atlantic Highlands. For that reason, she said, the formula “has to be fruitful for both neighboring towns.

Wells pointed out history of the educational system in Highlands and Atlantic Highlands, citing the many shared services, including a superintendent, the elementary schools and high school have shared even before regionalization of the three schools, and cost saving measures she said have already taken place with the PreK-12 regionalization of the two towns. That includes the convenience and good sense of one single board replacing three separate boards.

This makes it easier to streamline policies and procedures and align our three schools. In the years ahead there will be more positive changes; at this point our staff now has the ability to move throughout the district giving them more room for advancement, and career development,” The board member pointed out.

She blames the problems with the recently accomplished regionalization taking so long on the lack of direction from the Department of Education, identifying it as a governmental agency that wants and strives for regionalization yet has been a bit like a deer in the headlights when it came to merging these three small schools. “The administration, staff, students and community were all ready and on board, per the election. Our residents are ready to see any tax relief and this regionalization is just the beginning.,” she said.

As a board member, Wells feels she can administer policy by working with the Administration and strong leadership, saying “we are moving daily towards making strides to better the district. We are working hard to increase test scores while adding more programs to our overall portfolio. “

In response to the question of how she can improve that situation, Well pointed out that Covid has been a factor in education and “schools have their work cut out for them.” As a parent of youngsters in the 5th and 7th grades, as well as an adult daughter who went through the local school system several years ago, she said she is acutely aware of learning setbacks that happened. In addition to educational setbacks, there have also been social and emotional issues spawned during the Covid experience, and “we need time, and we are implementing new ways to teach our children for their overall success. “

Wells is seeking one of the two two-year terms to be decided in November by Highlands voters, along with Diane Knox, both running with the slogan, Hudson’s Bright future. Barring a surprise win by any write-in candidate, both Wells and Knox will be elected to the board in November.

There are contests for the one full three-year term, with newcomer Suzanne Thomas who is running under the slogan Leadership, Integrity, Community, being opposed by board member Irene Campell.

Four people are running for the two one-year terms representing Highlands, Donald Krueger, Regina Melnyk, Allison Burel and Kevin Ege.

Campbell, Wells, Krueger, Knox and Ege are all running under the slogan of Hudson’s Bright Future.

Rebecca Wells Rebecca Wells Rebecca Wells Rebecca Wells Rebecca Wells Rebecca Wells

What Lives Here

0
What Lives Here

A horror film filmed at the historic Strauss House in Atlantic Highlands is being featured at the Smodcastle Cinemas on First Avenue opening October 16th and continuing through October 20.

The film, “What Lives Here” was written and produced by Troy Burbank and his wife Michele Burbank.

Burbank, a filmmaker who hails from Leonardo is a graduate of Middletown High School South. The movie is the story of a junk removal company lured to an out-of-state project by a real-estate agent. The agent promises an untold fortune in exchange for removing the contents of a mansion with a sinister past.  What Lives Here

In addition to being filmed locally at one of the most historic mansions in Atlantic Highlands, the movie also highlights several other well-known sites in the Bayshore area, including Jaspan’s Hardware I and the Leonardo Motel as well as American Legion Post 338 in Leonardo. Production also took place at Snyder’s Tavern in West Shokan NY.  

What Lives Here” includes a broad cast, many of whom are local residents and some who have been featured in other films produced by Burbank and still available on Tubi and other media.

The cast includes Jeff Swanton, Catherine Parish, Ernie O’Donnell, Matt Riley, Ming Chen, Dan Gregory, Pete Hogan (son of Siobhan Fallon Hogan), Katie Walsh, Rob Ruvolo, Christian Keiber, Phil Kozma, Ugochukwu Onyianta, Saige Schoeller,  Andrew Bane, Kerry McGann, Tammy Owens, Ron Millkie ( who played officer Dorf in the original 1980 version of Friday the 13th ), Don Jameson, Jackie Adragna, Heidi Bird, Carol Kozma, Michele Burbank, Nick Burbank, Dave Harris, Barbara Presalomsky and Rob Schnoor.

This isn’t the first film using the Strauss Mansion as a site. An earlier movie, the1979 cult classic “Don’t go in the House” with director Joseph Ellison and starring Dan Grimaldi was also filmed at the Historical Society site that is on the National Register.

Nor is it Burbank’s only film that reaches broad audiences and is getting acclaim. Currently he has “Gone For The Weekend” available on Tubi at no cost, as well as his sitcom, “On Our Own”, which has six episodes and is also free on Tubi. His first horror film, “The House at 831”, which was also filmed locally, is available on DVD. Then there’ s the short horror called “The Last One to Leave” Wasted Blind.” 

Tickets for the Smodcastle Cinemas in Atlantic Highlands beginning next week can be purchased at the door and showtimes are available on the Smodcastle website for the cost of a regular movie ticket. Tickets will also be available each night on the showing. 

The movie is best suited for ages 15 and older due to language, brief nudity, and violent content.

The film was funded through investors including Phil Kozma and funds through garbage removal for the 430 movie by director Kevin Smith. 

The movie has already won awards including for Best director, Best Supporting actor Matt Riley and Best cinematography Marc Fratto .

What Lives Here What Lives Here What Lives Here What Lives Here What Lives Here